Trial Outcomes & Findings for Prescription Digital Therapeutic for the Treatment of Insomnia (NCT NCT04909229)
NCT ID: NCT04909229
Last Updated: 2025-07-28
Results Overview
Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)
COMPLETED
NA
100 participants
From baseline to 9 weeks post randomization
2025-07-28
Participant Flow
Participant milestones
| Measure |
PEAR-003b PDT Intervention
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
47
|
49
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 enrolled participant did not answer this survey question
Baseline characteristics by cohort
| Measure |
PEAR-003b PDT Intervention
n=48 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=50 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 12.09 • n=47 Participants • 1 enrolled participant did not answer this survey question
|
43.9 years
STANDARD_DEVIATION 12.69 • n=50 Participants • 1 enrolled participant did not answer this survey question
|
45.1 years
STANDARD_DEVIATION 12.40 • n=97 Participants • 1 enrolled participant did not answer this survey question
|
|
Sex/Gender, Customized
Female
|
35 Participants
n=48 Participants
|
34 Participants
n=50 Participants
|
69 Participants
n=98 Participants
|
|
Sex/Gender, Customized
Male
|
13 Participants
n=48 Participants
|
14 Participants
n=50 Participants
|
27 Participants
n=98 Participants
|
|
Sex/Gender, Customized
Non-binary/third gender
|
0 Participants
n=48 Participants
|
2 Participants
n=50 Participants
|
2 Participants
n=98 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=48 Participants
|
3 Participants
n=50 Participants
|
6 Participants
n=98 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=48 Participants
|
45 Participants
n=50 Participants
|
89 Participants
n=98 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=48 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=98 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
3 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=48 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=98 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=48 Participants
|
43 Participants
n=50 Participants
|
86 Participants
n=98 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=48 Participants
|
3 Participants
n=50 Participants
|
4 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=48 Participants
|
2 Participants
n=50 Participants
|
2 Participants
n=98 Participants
|
PRIMARY outcome
Timeframe: From baseline to 9 weeks post randomizationPopulation: Primary outcome measure was erased from study surveys and therefore not collected.
Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationPopulation: The primary outcome measure was not asked in the study surveys and therefore not collected. As a result, this secondary outcome measure, a component of the primary outcome, cannot be calculated.
Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationPopulation: The primary outcome measure was not asked in the study surveys and therefore not collected. As a result, this secondary outcome measure, a component of the primary outcome, cannot be calculated.
Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationPopulation: The primary outcome measure was not asked in the study surveys and therefore not collected. As a result, this secondary outcome measure, a component of the primary outcome, cannot be calculated.
Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationDepressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=27 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Depressive Symptoms
|
-2.0 score on a scale
Interval -4.0 to 0.0
|
-1.5 score on a scale
Interval -5.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationDepressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=20 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Depressive Symptoms
|
-2.0 score on a scale
Interval -5.0 to 1.0
|
-2.0 score on a scale
Interval -5.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationDepressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=22 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Depressive Symptoms
|
-2.0 score on a scale
Interval -4.0 to 1.0
|
-4.0 score on a scale
Interval -8.0 to -1.0
|
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationDepressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=23 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Depressive Symptoms
|
-2.0 score on a scale
Interval -8.0 to 0.0
|
0.0 score on a scale
Interval -4.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationThe General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=27 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Anxiety
|
-2.0 units on a scale
Interval -5.0 to 1.0
|
-1.0 units on a scale
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationThe General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=20 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Anxiety
|
-1.0 score on a scale
Interval -3.0 to 2.0
|
-1.0 score on a scale
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationThe General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=22 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Anxiety
|
-1.0 score on a scale
Interval -3.0 to 2.0
|
-1.0 score on a scale
Interval -4.0 to 0.0
|
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationThe General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=23 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Anxiety
|
-2.0 score on a scale
Interval -5.0 to 1.0
|
-1.0 score on a scale
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationThe Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=27 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Stress
|
-1.0 score on a scale
Interval -3.0 to 2.0
|
-0.5 score on a scale
Interval -3.0 to 2.0
|
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationThe Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=30 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=20 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Stress
|
0.0 score on a scale
Interval -2.0 to 3.0
|
-1.5 score on a scale
Interval -4.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationThe Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=22 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Stress
|
-1.0 score on a scale
Interval -3.0 to 1.0
|
-3.0 score on a scale
Interval -4.0 to 0.0
|
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationThe Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=23 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Stress
|
0.0 score on a scale
Interval -3.0 to 3.0
|
-1.0 score on a scale
Interval -4.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationChange in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=27 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Quality of Life (PCS)
|
-3.0 score on a scale
Interval -6.5 to 0.3
|
-1.1 score on a scale
Interval -5.3 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationChange in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=20 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Quality of Life (PCS)
|
0.5 score on a scale
Interval -4.3 to 4.8
|
-2.6 score on a scale
Interval -7.2 to 1.4
|
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationChange in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=22 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Quality of Life (PCS)
|
-1.2 score on a scale
Interval -7.6 to 3.5
|
-2.4 score on a scale
Interval -9.4 to 0.1
|
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationChange in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=23 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Quality of Life (PCS)
|
-1.0 score on a scale
Interval -5.0 to 3.8
|
-4.1 score on a scale
Interval -8.3 to 0.4
|
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationDaytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=27 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Daytime Sleepiness
|
-2.0 score on a scale
Interval -4.0 to 0.0
|
0.0 score on a scale
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationDaytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=20 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Daytime Sleepiness
|
-2.0 score on a scale
Interval -3.0 to -0.5
|
0.0 score on a scale
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationDaytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=22 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Daytime Sleepiness
|
0.0 score on a scale
Interval -3.0 to 1.0
|
-2.0 score on a scale
Interval -4.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationDaytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=23 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Daytime Sleepiness
|
-1.0 score on a scale
Interval -3.0 to 0.0
|
0.0 score on a scale
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationPopulation: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationPopulation: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationPopulation: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationPopulation: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationPopulation: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationPopulation: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationPopulation: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationPopulation: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationChange in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=38 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=35 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Sleep Efficiency
|
14 percentage points
Standard Deviation 21.1
|
12.1 percentage points
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationChange in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=27 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Sleep Efficiency
|
17.5 percentage points
Standard Deviation 12.7
|
13.8 percentage points
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationChange in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=27 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=24 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Sleep Efficiency
|
14.9 percentage points
Standard Deviation 16.4
|
13.5 percentage points
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationChange in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=15 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=8 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Sleep Efficiency
|
11.6 percentage points
Standard Deviation 15.6
|
15.8 percentage points
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationChange in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=38 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=36 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Sleep Onset Latency
|
0.15 hours
Standard Deviation 2.21
|
-0.193 hours
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationChange in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=28 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=31 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Sleep Onset Latency
|
-0.513 hours
Standard Deviation 2.058
|
-0.765 hours
Standard Deviation 1.728
|
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationChange in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=28 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=25 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Sleep Onset Latency
|
-0.926 hours
Standard Deviation 1.729
|
-0.94 hours
Standard Deviation 1.636
|
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationChange in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=15 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=9 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Sleep Onset Latency
|
-0.955 hours
Standard Deviation 1.35
|
0.184 hours
Standard Deviation 1.826
|
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationThe Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 9 weeks post-randomization.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=27 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=31 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Health Utility Score
|
1.7 percent change
Standard Error 1.8
|
-0.3 percent change
Standard Error 1.3
|
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationThe Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 21 weeks post-randomization.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=20 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Health Utility Score
|
6.8 percentage change
Standard Error 3.1
|
-1.6 percentage change
Standard Error 1.5
|
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationThe Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 35 weeks post-randomization.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=22 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Health Utility Score
|
-3.8 percentage change
Standard Error 2.5
|
2.6 percentage change
Standard Error 1.8
|
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationThe Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 61 weeks post-randomization.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=23 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=22 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Health Utility Score
|
3.7 percentage change
Standard Error 2.8
|
0.5 percentage change
Standard Error 2.2
|
SECONDARY outcome
Timeframe: From baseline to 9 weeks post-randomizationChange in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=27 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Quality of Life (MCS)
|
2.2 score on a scale
Interval -0.4 to 8.1
|
3.0 score on a scale
Interval -1.2 to 6.8
|
SECONDARY outcome
Timeframe: From baseline to 21 weeks post-randomizationChange in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=20 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=30 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Quality of Life (MCS)
|
1.7 score on a scale
Interval -5.2 to 12.3
|
2.0 score on a scale
Interval -1.6 to 7.7
|
SECONDARY outcome
Timeframe: From baseline to 35 weeks post-randomizationChange in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=22 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Quality of Life (MCS)
|
3.2 score on a scale
Interval -5.4 to 6.4
|
5.7 score on a scale
Interval -1.0 to 9.9
|
SECONDARY outcome
Timeframe: From baseline to 61 weeks post-randomizationChange in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.
Outcome measures
| Measure |
PEAR-003b PDT Intervention
n=23 Participants
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
Control Arm
n=21 Participants
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips.
|
|---|---|---|
|
Change in Quality of Life (MCS)
|
1.9 score on a scale
Interval -2.9 to 6.7
|
2.2 score on a scale
Interval -2.5 to 10.8
|
Adverse Events
PEAR-003b PDT Intervention
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place