Trial Outcomes & Findings for Treating Sleep Apnea in Women Veterans (NCT NCT03377452)
NCT ID: NCT03377452
Last Updated: 2024-05-24
Results Overview
Number of nights positive airway pressure (PAP) was used \>=4 hours during the first 90 days measured by remote monitoring. Number of nights range from 0 to 90 nights. More nights indicate better outcome. Remote monitoring data were available for all participants even if lost to follow-up for other measures. The sample size for this outcome is larger than for other outcomes as a result.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Three months after PAP initiation
Results posted on
2024-05-24
Participant Flow
Participant milestones
| Measure |
Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA)
Six session manual-based program using acceptance and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education.
Sessions delivered in individual format, either in-person or via telehealth.
|
Non-directive Sleep Apnea Education Control
Six session sleep apnea and PAP education program.
Sessions delivered in individual format, either in-person or via telehealth.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
46
|
|
Overall Study
Post Treatment
|
40
|
44
|
|
Overall Study
3 Month Follow-up
|
39
|
40
|
|
Overall Study
COMPLETED
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA)
Six session manual-based program using acceptance and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education.
Sessions delivered in individual format, either in-person or via telehealth.
|
Non-directive Sleep Apnea Education Control
Six session sleep apnea and PAP education program.
Sessions delivered in individual format, either in-person or via telehealth.
|
|---|---|---|
|
Overall Study
Refused assessment
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
Baseline Characteristics
Treating Sleep Apnea in Women Veterans
Baseline characteristics by cohort
| Measure |
Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA)
n=44 Participants
Six session manual-based program using acceptance and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education. Sessions delivered in individual format, either in-person or via telehealth.
|
Non-directive Sleep Apnea Education Control
n=46 Participants
Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sleep Quality
|
9.4 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 4.3 • n=7 Participants
|
9.3 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Baseline AHI
|
23.3 mean events per hour
STANDARD_DEVIATION 15.4 • n=5 Participants
|
20.5 mean events per hour
STANDARD_DEVIATION 12.0 • n=7 Participants
|
21.9 mean events per hour
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Insomnia Severity Index
|
15.4 units on a scale
STANDARD_DEVIATION 5.7 • n=5 Participants
|
12.7 units on a scale
STANDARD_DEVIATION 6.3 • n=7 Participants
|
14.0 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Three months after PAP initiationNumber of nights positive airway pressure (PAP) was used \>=4 hours during the first 90 days measured by remote monitoring. Number of nights range from 0 to 90 nights. More nights indicate better outcome. Remote monitoring data were available for all participants even if lost to follow-up for other measures. The sample size for this outcome is larger than for other outcomes as a result.
Outcome measures
| Measure |
Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA)
n=44 Participants
Six session manual-based program using acceptance-and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education.
Sessions delivered in individual format, either in-person or via telehealth.
|
Non-directive Sleep Apnea Education Control
n=46 Participants
Six session sleep apnea and PAP education program.
Sessions delivered in individual format, either in-person or via telehealth.
|
|---|---|---|
|
PAP Adherence
|
32.9 Number of nights
Standard Error 4.49
|
25.67 Number of nights
Standard Error 4.03
|
PRIMARY outcome
Timeframe: Baseline, Three months from the date of the last intervention/control session (typically 12-16 weeks after the final session)Self-reported sleep quality assessed with a brief patient questionnaire assessing multiple aspects of sleep quality. 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. This measure is available only for participants who were not lost to follow-up.
Outcome measures
| Measure |
Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA)
n=39 Participants
Six session manual-based program using acceptance-and commitment therapy (ACT) framework, behavior change strategies and sleep apnea/PAP education.
Sessions delivered in individual format, either in-person or via telehealth.
|
Non-directive Sleep Apnea Education Control
n=40 Participants
Six session sleep apnea and PAP education program.
Sessions delivered in individual format, either in-person or via telehealth.
|
|---|---|---|
|
Sleep Quality by Patient-reported Sleep Questionnaire
Baseline
|
9.41 score on a scale
Standard Error 0.63
|
9.11 score on a scale
Standard Error 0.61
|
|
Sleep Quality by Patient-reported Sleep Questionnaire
Three months from the date of the last intervention/control session
|
6.37 score on a scale
Standard Error 0.59
|
9.39 score on a scale
Standard Error 0.58
|
Adverse Events
Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-directive Sleep Apnea Education Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Martin, PhD
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