Treating Sleep Apnea in Women Veterans

January 11, 2024 updated by: VA Office of Research and Development

Diagnosis and Treatment of Sleep Apnea in Women Veterans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sepulveda, California, United States, 91343
        • VA Greater Los Angeles Healthcare System, Sepulveda, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAP Adherence
Time Frame: 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.
Three months after PAP initiation
Sleep Quality by Patient-reported Sleep Questionnaire
Time Frame: 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.
Baseline, Three months from the date of the last intervention/control session (typically 12-16 weeks after the final session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Jennifer L Martin, PhD, VA Greater Los Angeles Healthcare System, Sepulveda, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2018

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (Actual)

December 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 16-244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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