Treating Sleep Apnea in Women Veterans

Study Overview
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Brief Summary
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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 will undergo a sleep and health assessment that will be 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 will be randomly assigned to one of two 6-week education programs provided by a study interventionist. Follow-up sleep and health assessments will be conducted at the end of the 6-week education program and 3-months later. PAP usage data will be collected remotely for 12 months from PAP therapy initiation.

Detailed Description
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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 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 AHI of 5 or higher, and who meet all inclusion/exclusion criteria will be randomized to one of two educational programs. PAP devices, along with education about SDB and insomnia, will be provided to participants 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.

Official Title
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Diagnosis and Treatment of Sleep Apnea in Women Veterans

Conditions
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Sleep Apnea

Intervention / Treatment
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* Behavioral: Behavioral Education Intervention I
* Behavioral: Behavioral Education Intervention II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling women Veterans aged 18 years and older Received care from a 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Individuals will be assigned to one of two educational programs simultaneously
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Education Intervention I<br>Manual-based education program focusing on sleep and sleep apnea provided in individual sessions. | Behavioral: Behavioral Education Intervention I<br>* Manual-based education program focusing on sleep and sleep apnea provided in individual sessions.<br>|
| Experimental: Behavioral Education Intervention II<br>Manual-based education program focusing on sleep and sleep apnea provided in individual sessions. | Behavioral: Behavioral Education Intervention II<br>* Manual-based education program focusing on sleep and sleep apnea provided in individual sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAP adherence | Percent of nights with 4 or more hours of PAP use. | 3 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. | 3 months from randomization |