An interventional study of Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA) and Non-directive sleep apnea education control in Sleep Apnea, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
This study is a randomized controlled trial (RCT) to test two sleep apnea education programs for women Veterans newly diagnosed with sleep apnea (SA) who are prescribed positive airway pressure (PAP) therapy. This education program is designed to improve participants' sleep quality and help them to adjust to PAP therapy.
Participants undergo a sleep and health assessment that is performed prior to beginning the education program. This assessment includes wearing a wrist actigraph to measure sleep and wake periods for 7 days and nights, and answering questionnaires about sleep habits and health. Participants are randomly assigned to one of two 6-week programs (intervention or educational control) provided by a study interventionist. Follow-up sleep and health assessments will be conducted at the end of the 6-week program and 3-months later. PAP usage data will be collected remotely for 6-months from PAP therapy initiation.
Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments and mortality risk. Although SDB is more common among men than women, it still impacts 17% of women in the general population. [The investigators' preliminary evidence suggests it is even more common among women Veterans who receive VA care.] The recommended first-line therapy for most patients with SDB is positive airway pressure therapy (PAP). Published studies show that women have lower PAP adherence than men, particularly in the US, yet the investigators are not aware of data comparing men and women Veterans. Because women Veterans experience significant sleep disturbance and other consequences of sleep disorders, adjusting to PAP therapy may be quite difficult. To date, studies have not tested interventions specifically designed to improve PAP adherence among women, accounting for important sleep-related and social factors.
This study is a randomized controlled trial (RCT) to test the efficacy of a program combining patient education with behavioral techniques and exercises from acceptance and commitment therapy (ACT) to improve adherence to PAP therapy. Women Veterans 18 years and older, who have received care at the VA Greater Los Angeles Healthcare System, and who have at least 1 risk factor for SDB will be recruited for this study. Screening for sleep apnea will be performed in the participant's home using a WatchPAT device. Both objective (actigraphy) and self-report (questionnaire/diary) sleep measures will be collected, as well as other health-related measures. Participants with an Apnea-Hypopnea Index (AHI) of 5 or higher, and who meet all inclusion/exclusion criteria will be randomized to one of two programs: Acceptance and the Behavioral Changes to Treatment of Sleep Apnea (ABC-SA) or a non-directive sleep apnea education control.
PAP devices, along with education about SDB and sleep, will be provided to participants as part of the 6-session intervention and control programs. Follow-up assessments will be conducted immediately following the intervention/control and after 3-months.
Main study outcomes (sleep quality and PAP adherence) will be assessed 3 months after PAP initiation, and PAP adherence will be tracked remotely for 6 months. Data will be analyzed using "intention to treat" principles, using appropriate statistical methods for clinical trials.
Exclusion Criteria:
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.
Behavioral: Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA)
Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth.
Behavioral: Non-directive sleep apnea education control
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.
Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth.
PAP Adherence
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.
Time frame: Three months after PAP initiation
Sleep Quality by Patient-reported Sleep Questionnaire
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.
Time frame: Baseline, Three months from the date of the last intervention/control session (typically 12-16 weeks after the final session)
| Milestone | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control |
|---|---|---|
| Started | 44 | 46 |
| Post treatment | 40 | 44 |
| 3 month follow-up | 39 | 40 |
| Completed | 39 | 40 |
| Not completed | 5 | 6 |
| Withdrew: Refused assessment | 0 | 2 |
| Withdrew: Lost to follow-up | 5 | 4 |
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.
| Number of nights | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control |
|---|---|---|
| PAP Adherence | 32.9 ± 4.49 | 25.67 ± 4.03 |
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.
| score on a scale | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control |
|---|---|---|
| Baseline | 9.41 ± 0.63 | 9.11 ± 0.61 |
| Three months from the date of the last intervention/control session | 6.37 ± 0.59 | 9.39 ± 0.58 |
Collected over Adverse event data were collected from enrollment and through the end of the 3-month follow-up period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Non-directive Sleep Apnea Education Control | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Age, Continuous(years) | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control | Total |
|---|---|---|---|
| Mean | 53.7 ± 13.2 | 52.7 ± 12.6 | 53.2 ± 12.8 |
| Sex: Female, Male(Participants) | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control | Total |
|---|---|---|---|
| Female | 44 | 46 | 90 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 14 | 25 |
| Not Hispanic or Latino | 33 | 32 | 65 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 14 | 10 | 24 |
| White | 27 | 27 | 54 |
| More than one race | 2 | 4 | 6 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Sleep Quality(units on a scale) | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control | Total |
|---|---|---|---|
| Mean | 9.4 ± 4.1 | 9.1 ± 4.3 | 9.3 ± 4.2 |
| Baseline AHI(mean events per hour) | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control | Total |
|---|---|---|---|
| Mean | 23.3 ± 15.4 | 20.5 ± 12.0 | 21.9 ± 13.8 |
| Insomnia Severity Index(units on a scale) | Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA) | Non-directive Sleep Apnea Education Control | Total |
|---|---|---|---|
| Mean | 15.4 ± 5.7 | 12.7 ± 6.3 | 14.0 ± 6.1 |
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