Treating Sleep Apnea in Women Veterans

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2022-11-30

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 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.

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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 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.

Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Individuals will be assigned to one of two programs simultaneously

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants and outcome assessors will be blinded to group assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

Acceptance and the Behavioral Changes to Treat Sleep Apnea (ACB-SA)

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Non-directive sleep apnea education control

Intervention Type BEHAVIORAL

Six session sleep apnea and PAP education program. Sessions delivered in individual format, either in-person or via telehealth.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No