Trial Outcomes & Findings for Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (NCT NCT03534284)
NCT ID: NCT03534284
Last Updated: 2024-02-05
Results Overview
summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention
COMPLETED
PHASE3
126 participants
Week 7
2024-02-05
Participant Flow
923 patients screened with Insomnia Severity Index (ISI). Of 411 identified as having insomnia (ISI score \>=10),179 declined study participation and 106 met exclusion criteria.
126 participants completed baseline measures before group assignment, including patient reported outcomes collected via Computer Assisted Telephone Interview (CATI) and nights using sleep aid on sedatives\&hypnotics CRF. Most (115) also completed baseline Actigraphy, although this was not required for study entry (randomization).
Participant milestones
| Measure |
CBT-I
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
41
|
|
Overall Study
Week 7 Primary Outcome
|
39
|
41
|
40
|
|
Overall Study
COMPLETED
|
36
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
3
|
Reasons for withdrawal
| Measure |
CBT-I
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
0
|
Baseline Characteristics
Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Baseline characteristics by cohort
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 15.2 • n=93 Participants
|
56.2 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
57.2 years
STANDARD_DEVIATION 12.7 • n=27 Participants
|
58.1 years
STANDARD_DEVIATION 13.9 • n=483 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
63 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
63 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
100 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
78 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Time since starting dialysis, months
|
26.4 months
n=93 Participants
|
36.3 months
n=4 Participants
|
28.2 months
n=27 Participants
|
30.9 months
n=483 Participants
|
PRIMARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Insomnia Severity Index (ISI) Short-term
|
12.47 score on a scale
Interval 10.68 to 14.26
|
11.97 score on a scale
Interval 10.23 to 13.72
|
13.05 score on a scale
Interval 11.29 to 14.82
|
PRIMARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Insomnia Severity Index (ISI) Long-term
|
11.34 score on a scale
Interval 9.28 to 13.41
|
12.2 score on a scale
Interval 10.2 to 14.19
|
11.85 score on a scale
Interval 9.83 to 13.88
|
SECONDARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term
|
9.44 score on a scale
Interval 8.32 to 10.55
|
11.09 score on a scale
Interval 10.0 to 12.18
|
12.39 score on a scale
Interval 11.28 to 13.49
|
SECONDARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term
|
9.15 score on a scale
Interval 7.89 to 10.4
|
10.49 score on a scale
Interval 9.26 to 11.71
|
9.95 score on a scale
Interval 8.71 to 11.19
|
SECONDARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term
|
7.67 score on a scale
Interval 6.37 to 8.97
|
8.46 score on a scale
Interval 7.19 to 9.74
|
7.5 score on a scale
Interval 6.21 to 8.79
|
SECONDARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term
|
7.27 score on a scale
Interval 5.88 to 8.65
|
8.12 score on a scale
Interval 6.76 to 9.47
|
7.94 score on a scale
Interval 6.57 to 9.31
|
SECONDARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term
|
32.55 score on a scale
Interval 29.51 to 35.59
|
28.76 score on a scale
Interval 25.77 to 31.75
|
28.5 score on a scale
Interval 25.48 to 31.51
|
SECONDARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term
|
32.65 score on a scale
Interval 29.44 to 35.86
|
28.53 score on a scale
Interval 25.39 to 31.68
|
30.7 score on a scale
Interval 27.52 to 33.87
|
SECONDARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term
|
4.50 units on a scale
Interval 3.74 to 5.27
|
4.53 units on a scale
Interval 3.78 to 5.29
|
4.21 units on a scale
Interval 3.44 to 4.98
|
SECONDARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term
|
4.14 units on a scale
Interval 3.34 to 4.95
|
4.32 units on a scale
Interval 3.53 to 5.11
|
4.80 units on a scale
Interval 4.0 to 5.6
|
SECONDARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term
|
4.18 units on a scale
Interval 3.32 to 5.05
|
4.07 units on a scale
Interval 3.22 to 4.91
|
3.61 units on a scale
Interval 2.75 to 4.46
|
SECONDARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term
|
3.88 units on a scale
Interval 3.07 to 4.68
|
3.71 units on a scale
Interval 2.93 to 4.5
|
4.30 units on a scale
Interval 3.5 to 5.09
|
SECONDARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term
|
6.98 score on a scale
Interval 5.47 to 8.49
|
7.93 score on a scale
Interval 6.45 to 9.4
|
8.27 score on a scale
Interval 6.78 to 9.75
|
SECONDARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term
|
6.61 score on a scale
Interval 5.09 to 8.14
|
8.04 score on a scale
Interval 6.55 to 9.53
|
7.34 score on a scale
Interval 5.83 to 8.84
|
SECONDARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term
|
5.18 score on a scale
Interval 3.54 to 6.82
|
6.18 score on a scale
Interval 4.58 to 7.79
|
7.04 score on a scale
Interval 5.42 to 8.66
|
SECONDARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term
|
5.27 score on a scale
Interval 3.56 to 6.98
|
6.35 score on a scale
Interval 4.67 to 8.02
|
6.29 score on a scale
Interval 4.6 to 7.99
|
SECONDARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term
|
31.87 score on a scale
Interval 29.13 to 34.61
|
32.37 score on a scale
Interval 29.66 to 35.08
|
32.80 score on a scale
Interval 30.06 to 35.53
|
SECONDARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term
|
33.21 score on a scale
Interval 30.36 to 36.07
|
32.07 score on a scale
Interval 29.28 to 34.85
|
31.85 score on a scale
Interval 29.04 to 34.67
|
SECONDARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term
|
49.53 score on a scale
Interval 46.62 to 52.44
|
47.77 score on a scale
Interval 44.9 to 50.65
|
48.29 score on a scale
Interval 45.38 to 51.19
|
SECONDARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term
|
50.44 score on a scale
Interval 47.59 to 53.29
|
49.23 score on a scale
Interval 46.45 to 52.01
|
51.38 score on a scale
Interval 48.56 to 54.19
|
SECONDARY outcome
Timeframe: Week 7Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Cumulative Weekly Use of Sedatives/Hypnotics - Short-term
|
1.65 days
Interval 0.93 to 2.37
|
1.29 days
Interval 0.66 to 1.92
|
1.01 days
Interval 0.35 to 1.67
|
SECONDARY outcome
Timeframe: Week 25Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=43 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Cumulative Weekly Use of Sedatives/Hypnotics - Long-term
|
1.58 days
Interval 0.93 to 2.24
|
2.62 days
Interval 1.69 to 3.56
|
2.42 days
Interval 1.51 to 3.32
|
SECONDARY outcome
Timeframe: Week 7Population: N=119 participants had at least one time point (week 0, week 7, and/or week 25) with actigraphy data and were included in model to estimate means at week 7 and week 25. Seven had no actigraphy collected: 4 declined to wear the watch; 3 had data that could not be scored due to inconsistent use.
Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 7 describing the short-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=41 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=41 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=37 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Objective Measure of Sleep - Short-term
|
68.03 percentage of time in bed asleep
Interval 62.41 to 73.65
|
70.94 percentage of time in bed asleep
Interval 65.94 to 75.94
|
70.87 percentage of time in bed asleep
Interval 65.94 to 75.8
|
SECONDARY outcome
Timeframe: Week 25Population: N=119 participants had at least one time point (week 0, week 7, or week 25) with actigraphy data and were included in model to estimate means at week 7 and week 25. Seven had no actigraphy collected: 4 declined to wear the watch; 3 had data that could not be scored due to inconsistent use.
Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 25 describing the long-term effect of the intervention
Outcome measures
| Measure |
CBT-I
n=41 Participants
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=41 Participants
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=37 Participants
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Objective Measure of Sleep - Long-term
|
68.99 percentage of time in bed asleep
Interval 64.57 to 73.41
|
71.6 percentage of time in bed asleep
Interval 66.77 to 76.43
|
71.57 percentage of time in bed asleep
Interval 65.49 to 77.65
|
Adverse Events
CBT-I
Medication- Trazodone
Medication- Placebo
Serious adverse events
| Measure |
CBT-I
n=43 participants at risk
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 participants at risk
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 participants at risk
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Cardiac disorders
Hospitalization / Death
|
2.3%
1/43 • Number of events 1 • 6 months
|
19.0%
8/42 • Number of events 13 • 6 months
|
9.8%
4/41 • Number of events 4 • 6 months
|
|
Blood and lymphatic system disorders
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
2.4%
1/42 • Number of events 1 • 6 months
|
0.00%
0/41 • 6 months
|
|
Endocrine disorders
Hospitalization / Death
|
2.3%
1/43 • Number of events 1 • 6 months
|
0.00%
0/42 • 6 months
|
0.00%
0/41 • 6 months
|
|
Gastrointestinal disorders
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
2.4%
1/42 • Number of events 2 • 6 months
|
4.9%
2/41 • Number of events 4 • 6 months
|
|
Infections and infestations
Hospitalization / Death
|
9.3%
4/43 • Number of events 5 • 6 months
|
11.9%
5/42 • Number of events 7 • 6 months
|
17.1%
7/41 • Number of events 9 • 6 months
|
|
Injury, poisoning and procedural complications
Hospitalization / Death
|
2.3%
1/43 • Number of events 1 • 6 months
|
2.4%
1/42 • Number of events 1 • 6 months
|
4.9%
2/41 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Hospitalization / Death
|
4.7%
2/43 • Number of events 2 • 6 months
|
0.00%
0/42 • 6 months
|
4.9%
2/41 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Hospitalization / Death
|
2.3%
1/43 • Number of events 1 • 6 months
|
0.00%
0/42 • 6 months
|
0.00%
0/41 • 6 months
|
|
Renal and urinary disorders
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
0.00%
0/42 • 6 months
|
2.4%
1/41 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
7.1%
3/42 • Number of events 4 • 6 months
|
4.9%
2/41 • Number of events 2 • 6 months
|
|
Surgical and medical procedures
Hospitalization / Death
|
7.0%
3/43 • Number of events 3 • 6 months
|
7.1%
3/42 • Number of events 6 • 6 months
|
7.3%
3/41 • Number of events 4 • 6 months
|
|
Vascular disorders
Hospitalization / Death
|
2.3%
1/43 • Number of events 1 • 6 months
|
7.1%
3/42 • Number of events 3 • 6 months
|
0.00%
0/41 • 6 months
|
Other adverse events
| Measure |
CBT-I
n=43 participants at risk
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
|
Medication- Trazodone
n=42 participants at risk
Trazodone (50-100 mg):
Trazodone: trazodone tablet
|
Medication- Placebo
n=41 participants at risk
Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
2.4%
1/42 • Number of events 1 • 6 months
|
0.00%
0/41 • 6 months
|
|
Cardiac disorders
Hospitalization / Death
|
4.7%
2/43 • Number of events 3 • 6 months
|
4.8%
2/42 • Number of events 2 • 6 months
|
9.8%
4/41 • Number of events 5 • 6 months
|
|
Endocrine disorders
Hospitalization / Death
|
2.3%
1/43 • Number of events 1 • 6 months
|
2.4%
1/42 • Number of events 1 • 6 months
|
0.00%
0/41 • 6 months
|
|
Eye disorders
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
0.00%
0/42 • 6 months
|
2.4%
1/41 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Hospitalization / Death
|
11.6%
5/43 • Number of events 6 • 6 months
|
7.1%
3/42 • Number of events 3 • 6 months
|
7.3%
3/41 • Number of events 3 • 6 months
|
|
Infections and infestations
Hospitalization / Death
|
4.7%
2/43 • Number of events 2 • 6 months
|
7.1%
3/42 • Number of events 3 • 6 months
|
4.9%
2/41 • Number of events 3 • 6 months
|
|
Injury, poisoning and procedural complications
Hospitalization / Death
|
14.0%
6/43 • Number of events 7 • 6 months
|
7.1%
3/42 • Number of events 3 • 6 months
|
9.8%
4/41 • Number of events 7 • 6 months
|
|
Metabolism and nutrition disorders
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
2.4%
1/42 • Number of events 1 • 6 months
|
2.4%
1/41 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Hospitalization / Death
|
7.0%
3/43 • Number of events 4 • 6 months
|
7.1%
3/42 • Number of events 4 • 6 months
|
4.9%
2/41 • Number of events 2 • 6 months
|
|
Nervous system disorders
Hospitalization / Death
|
4.7%
2/43 • Number of events 3 • 6 months
|
4.8%
2/42 • Number of events 2 • 6 months
|
2.4%
1/41 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Hospitalization / Death
|
2.3%
1/43 • Number of events 1 • 6 months
|
9.5%
4/42 • Number of events 4 • 6 months
|
0.00%
0/41 • 6 months
|
|
Renal and urinary disorders
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
0.00%
0/42 • 6 months
|
2.4%
1/41 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization / Death
|
2.3%
1/43 • Number of events 2 • 6 months
|
2.4%
1/42 • Number of events 1 • 6 months
|
0.00%
0/41 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
2.4%
1/42 • Number of events 1 • 6 months
|
7.3%
3/41 • Number of events 3 • 6 months
|
|
Surgical and medical procedures
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
4.8%
2/42 • Number of events 2 • 6 months
|
7.3%
3/41 • Number of events 3 • 6 months
|
|
Vascular disorders
Hospitalization / Death
|
0.00%
0/43 • 6 months
|
2.4%
1/42 • Number of events 1 • 6 months
|
2.4%
1/41 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place