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IIR 16-244 – HSR&D Study

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IIR 16-244
Diagnosis and Treatment of Sleep Apnea in Women Veterans
Jennifer L Martin PhD
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, CA
Funding Period: February 2018 - January 2022

BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
Aim 1: Test the efficacy of the ABC-SA program in improving PAP adherence, compared to a control program modeled after usual care, for women Veterans with SDB.

Aim 2: Test the efficacy of the ABC-SA program for improving objectively-measured and patient reported sleep quality, compared to the control program.

Exploratory Aim 3: Test the efficacy of the ABC-SA program for improving quality of life and symptoms of depression, compared to the control program.

METHODS:
This study is a randomized controlled trial (RCT) to test the efficacy of a program combining patient education with behavioral techniques 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 sleep disordered breathing (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 AHI of 5 or higher, and who meet all inclusion/exclusion criteria will be randomized to one of two educational programs.

Participants will be randomized to two groups. PAP devices, along with education about SDB and insomnia, will be provided to participants in both groups as part of the 6-session intervention. Follow-up assessments will be conducted immediately following the intervention 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 12 months. Data will be analyzed using "intention to treat" principles, using appropriate statistical methods for clinical trials.

FINDINGS/RESULTS:
This is a new study and there are no findings to report.

IMPACT:
The long-term objective of this program of research is to advance VA toward efficient and optimal implementation of best practices for treatment of all sleep disorders among women Veterans. We see the proposed work as a critical step in that process.

PUBLICATIONS:
None at this time.


DRA: Aging, Older Veterans' Health and Care, Health Systems
DRE: Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational
Keywords: Adherence, Outcomes - Patient
MeSH Terms: none