Treating Sleep Apnea in Women Veterans

Not Applicable

Completed

• Conditions: Sleep Apnea
• Interventions: Behavioral: Non-directive sleep apnea education control; Behavioral: Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA)

• Registration Number: NCT03377452
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-19
• Study Start: 2018-06-26
• Primary Completion: 2022-03-31
• Study Completion: 2022-11-30
• Results First Submitted: 2023-03-30
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Results First Posted: 2024-05-24
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Community-dwelling women Veterans aged 18 years and older
• Received care from a Veterans Health Administration (VHA) facility
• Have a least one risk factor for sleep apnea (e.g., hypertension, obesity, or age 50 years or older)
• Diagnosed as having sleep apnea with an AHI of 5 or greater

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Exclusion Criteria

• Currently using a treatment for sleep apnea
• Current pregnancy
• Active substance user or in recovery with < 90 days of sobriety
• Too ill to engage in study procedures
• Do not have transportation to the medical center
• Unable to self-consent (e.g., due to cognitive impairment)
• Unstable housing
• Does not have sleep apnea
• Another sleep disorder (e.g., restless legs syndrome, circadian rhythm sleep disorder) accounts for sleep disturbance
• No sleep complaints or symptoms

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-directive sleep apnea education control	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.
Acceptance and the Behavioral Changes to Treat Sleep Apnea (ABC-SA)	Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-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.

Primary Outcome Measures

Name	Time	Method
PAP Adherence	Three months after PAP initiation	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.
Sleep Quality by Patient-reported Sleep Questionnaire	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.

Trial Locations

Locations (1)

VA Greater Los Angeles Healthcare System, Sepulveda, CA; 🇺🇸 Sepulveda, California, United States