Treating Sleep Apnea in Women Veterans

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 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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Behavioral: Behavioral Education Intervention I; Behavioral: Behavioral Education Intervention II

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 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.

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jennifer L Martin, PhD, VA Greater Los Angeles Healthcare System, Sepulveda, CA

Study record dates

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): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• 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