Trial Outcomes & Findings for Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans (NCT NCT02027558)
NCT ID: NCT02027558
Last Updated: 2019-06-03
Results Overview
Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
Three months after randomization
Results posted on
2019-06-03
Participant Flow
Participant milestones
| Measure |
Behavioral Treatment
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
|
Active Control
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
63
|
|
Overall Study
Post-treatment
|
49
|
60
|
|
Overall Study
3-month Follow-up
|
53
|
58
|
|
Overall Study
6-month Follow-up
|
53
|
61
|
|
Overall Study
COMPLETED
|
53
|
61
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
Behavioral Treatment
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
|
Active Control
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Refused assessment
|
3
|
0
|
Baseline Characteristics
Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans
Baseline characteristics by cohort
| Measure |
Behavioral Treatment
n=62 Participants
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence education program provided by allied health personnel in individual sessions.
|
Active Control
n=63 Participants
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
63.7 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
63.2 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sleep quality
|
11.0 units on a scale
STANDARD_DEVIATION 3.9 • n=99 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 4.4 • n=107 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 4.1 • n=206 Participants
|
|
Sleep onset latency from diary
|
40.9 minutes
STANDARD_DEVIATION 41.1 • n=99 Participants
|
37.7 minutes
STANDARD_DEVIATION 27.3 • n=107 Participants
|
39.3 minutes
STANDARD_DEVIATION 34.7 • n=206 Participants
|
|
Wake after sleep onset from sleep diary
|
53.4 minutes
STANDARD_DEVIATION 49.6 • n=99 Participants
|
58.5 minutes
STANDARD_DEVIATION 58.7 • n=107 Participants
|
56.0 minutes
STANDARD_DEVIATION 54.2 • n=206 Participants
|
|
Sleep efficiency from sleep diary
|
70.1 percentage of time
STANDARD_DEVIATION 17.8 • n=99 Participants
|
69.9 percentage of time
STANDARD_DEVIATION 14.0 • n=107 Participants
|
70.0 percentage of time
STANDARD_DEVIATION 15.9 • n=206 Participants
|
|
Sleep efficiency from wrist actigraphy
|
77.7 percentage of time
STANDARD_DEVIATION 9.0 • n=99 Participants
|
78.1 percentage of time
STANDARD_DEVIATION 10.9 • n=107 Participants
|
77.9 percentage of time
STANDARD_DEVIATION 10.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: Three months after randomizationTotal score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Behavioral Treatment
n=62 Participants
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
.
|
Active Control
n=63 Participants
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
.
|
|---|---|---|
|
Sleep Quality
|
6.25 score on a scale
Standard Error 0.56
|
9.87 score on a scale
Standard Error 0.53
|
PRIMARY outcome
Timeframe: Three months after randomizationSleep onset latency (minutes to fall asleep) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
Outcome measures
| Measure |
Behavioral Treatment
n=62 Participants
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
.
|
Active Control
n=63 Participants
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
.
|
|---|---|---|
|
Sleep Onset Latency From Sleep Diary
|
22.80 minutes
Standard Error 3.86
|
35.77 minutes
Standard Error 3.74
|
PRIMARY outcome
Timeframe: Three months after randomizationWake after sleep onset (minutes awake from sleep onset to get up time) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.
Outcome measures
| Measure |
Behavioral Treatment
n=62 Participants
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
.
|
Active Control
n=63 Participants
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
.
|
|---|---|---|
|
Wake After Sleep Onset From Sleep Diary
|
20.42 minutes
Standard Error 4.31
|
40.67 minutes
Standard Error 4.16
|
PRIMARY outcome
Timeframe: Three months after randomizationSleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
Outcome measures
| Measure |
Behavioral Treatment
n=62 Participants
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
.
|
Active Control
n=63 Participants
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
.
|
|---|---|---|
|
Sleep Efficiency From Sleep Diary
|
86.24 percentage of time
Standard Error 1.69
|
75.69 percentage of time
Standard Error 1.64
|
PRIMARY outcome
Timeframe: Three months after randomizationSleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy. Scores range from 0 to 100 percent. Higher scores indicate better outcome.
Outcome measures
| Measure |
Behavioral Treatment
n=62 Participants
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
.
|
Active Control
n=63 Participants
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
.
|
|---|---|---|
|
Sleep Efficiency From Wrist Actigraphy
|
81.70 percentage of time
Standard Error 1.07
|
78.51 percentage of time
Standard Error 1.07
|
PRIMARY outcome
Timeframe: Three months after randomizationNumber of nights positive airway pressure (PAP) was used \>=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.
Outcome measures
| Measure |
Behavioral Treatment
n=62 Participants
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
.
|
Active Control
n=63 Participants
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
.
|
|---|---|---|
|
PAP Adherence
|
38.58 number of nights
Standard Error 3.89
|
21.16 number of nights
Standard Error 3.14
|
Adverse Events
Behavioral Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Active Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Behavioral Treatment
n=62 participants at risk
Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
|
Active Control
n=63 participants at risk
Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.6%
1/62 • Number of events 1 • Adverse event data were collected for 6 months.
|
0.00%
0/63 • Adverse event data were collected for 6 months.
|
Additional Information
Cathy Alessi, MD
VA Greater Los Angeles Healthcare System
Phone: 818-891-7711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place