Trial Outcomes & Findings for P20 Extending Sleep to Reverse Metabolic Syndrome (NCT NCT03596983)
NCT ID: NCT03596983
Last Updated: 2024-11-19
Results Overview
14-item questionnaire assessing acceptability of SASI. Items are ranked on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is the average item score and ranges from 1-5. Higher total scores indicate greater overall acceptability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Baseline
Results posted on
2024-11-19
Participant Flow
Participant milestones
| Measure |
Short Sleep Patients
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Short Sleep Patients
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
P20 Extending Sleep to Reverse Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
Short Sleep Patients
n=41 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline14-item questionnaire assessing acceptability of SASI. Items are ranked on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is the average item score and ranges from 1-5. Higher total scores indicate greater overall acceptability.
Outcome measures
| Measure |
Short Sleep Patients
n=44 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
SASI Acceptability Questionnaire Score at Pre-Intervention
|
3.91 score on a scale
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: Week 1514-item questionnaire assessing acceptability of SASI. Items are ranked on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is the average item score and ranges from 1-5. Higher total scores indicate greater overall acceptability.
Outcome measures
| Measure |
Short Sleep Patients
n=41 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
SASI Acceptability Questionnaire Score at Post-Intervention
|
4.3 score on a scale
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: BaselineThe percentage of screened participants who were enrolled in the study.
Outcome measures
| Measure |
Short Sleep Patients
n=81 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Recruitment Rate
|
54 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 15Percentage of Enrolled Participants who completed the 15-Week intervention.
Outcome measures
| Measure |
Short Sleep Patients
n=44 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Retention Rate
|
93 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 15The percentage of participants completing greater than or equal to 4 daily sleep diary entries per week for 80% or more of the intervention period.
Outcome measures
| Measure |
Short Sleep Patients
n=41 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
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Protocol Adherence Rate
|
99 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 15Data estimated using wrist actigraph.
Outcome measures
| Measure |
Short Sleep Patients
n=37 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Change in Sleep Duration
|
1.11 hours
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, Week 15128-item questionnaire asking participants to rank the level by which they have been bothered in the past week by common physical complaints people have, such as headaches, eye irritation, nasal congestion, etc. Items ranked on 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The total score is the average score of each item and ranges from 1-5; lower scores indicate less physical complaints. The change score is calculated as the change in scores between baseline and Week 15; the change score may range anywhere from 0-5.
Outcome measures
| Measure |
Short Sleep Patients
n=41 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Change in SAFTEE Questionnaire Scores
|
0.09 score on a scale
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Baseline, Week 15Estimated using accelerometer (count of steps).
Outcome measures
| Measure |
Short Sleep Patients
n=41 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Change in Physical Activity
|
-3576.17 Step Counts
Standard Deviation 16,620.33
|
SECONDARY outcome
Timeframe: Baseline, Week 159-item questionnaire assessing self-regulation as it pertains to sleep. Items rated on 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). The total score is the average score for each item; higher scores indicate greater self-regulation.
Outcome measures
| Measure |
Short Sleep Patients
n=41 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Change in Index of Self-Regulation (Sleep) Score
|
-0.16 score on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Baseline, Week 156-item assessment of fatigue in the morning. Lowest score - 6; Highest score - 30; Lower score indicates less fatigue in the morning.
Outcome measures
| Measure |
Short Sleep Patients
n=37 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Change in PROMIS Fatigue 6a Morning Score
|
4.95 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline, Week 156-item assessment of fatigue in the Evening. Lowest score - 6; Highest score - 30; Lower score indicates less fatigue in the evening.
Outcome measures
| Measure |
Short Sleep Patients
n=37 Participants
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
Change in PROMIS Fatigue 6a Evening Score
|
5.36 score on a scale
Standard Deviation 5.3
|
Adverse Events
Short Sleep Patients
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Short Sleep Patients
n=44 participants at risk
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Sleep Intervention: - Sleep Diaries (Daily)
* Fitbit 24/7
* Phone/ video conference calls (weekly with study team)
* Epworth Sleepiness Scale (weekly)
* PROMIS fatigue scale-evening (weekly)
Week 2 Intervention: - Sleep Diaries (Daily)
* Phone Calls (weekly with study team)
* Wrist Accelerometry and fitbit 24/7 for 14 days
* SAFTEE Questionnaire
* ASA24
* Behavioral risk factor surveillance system (smoking and alcohol use questions)
* Psychological well-being (SF36)
* Index of Self Regulation
* PROMIS fatigue scale-morning (weekly)
* PROMIS fatigue scale-evening (weekly)
* Epworth Sleepiness Scale (weekly)
|
|---|---|
|
General disorders
Minor skin irritation on wrist while wearing the accelerometer.
|
4.5%
2/44 • 15 Weeks
A systematic method was used for determining adverese events using a standrad questionnaire in the REDCAp databse (C-DASH). Participants were queried for adverse events weekly at the end of their intervention session.
|
|
General disorders
Finger Injury
|
2.3%
1/44 • 15 Weeks
A systematic method was used for determining adverese events using a standrad questionnaire in the REDCAp databse (C-DASH). Participants were queried for adverse events weekly at the end of their intervention session.
|
|
Gastrointestinal disorders
Hospitalized for C-diff
|
2.3%
1/44 • 15 Weeks
A systematic method was used for determining adverese events using a standrad questionnaire in the REDCAp databse (C-DASH). Participants were queried for adverse events weekly at the end of their intervention session.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place