Treating Sleep Apnea in Women Veterans

• ClinicalTrials.gov Identifier: NCT03377452
• Recruitment Status: Recruiting
• First Posted: December 19, 2017
• Last Update Posted: January 31, 2022
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea	Behavioral: Behavioral Education Intervention I; Behavioral: Behavioral Education Intervention II	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Individuals will be assigned to one of two educational programs simultaneously
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Participants and outcome assessors will be blinded to group assignment.
• Primary Purpose: Treatment
• Official Title: Diagnosis and Treatment of Sleep Apnea in Women Veterans
• Actual Study Start Date: June 26, 2018
• Estimated Primary Completion Date: March 31, 2022
• Estimated Study Completion Date: September 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. PAP adherence [ Time Frame: 3 months after PAP initiation ]
   Percent of nights with 4 or more hours of PAP use.
2. sleep quality by patient-reported sleep questionnaire [ Time Frame: 3 months from randomization ]
   Self-reported sleep quality assessed with a brief patient questionnaire assessing multiple aspects of sleep quality.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: This study is for women Veterans.
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Jennifer L Martin, PhD; (818) 891-7711 ext 36080; jennifer.martin@va.gov

Contact: Karen J Camacho, MPH; (818) 891-7711 ext 36083; Karen.Camacho@va.gov

Locations

United States, California

VA Greater Los Angeles Healthcare System, Sepulveda, CA; Recruiting

Sepulveda, California, United States, 91343

Contact: Scott E Krahl, PhD MA BA 818-895-5861 scott.krahl@va.gov

Sub-Investigator: Cathy A Alessi, MD

Sub-Investigator: Elizabeth M Yano, PhD MSPH

Principal Investigator: Jennifer L Martin, PhD

Sponsors and Collaborators

VA Office of Research and Development

Investigators

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

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03377452
• Other Study ID Numbers: IIR 16-244
• First Posted: December 19, 2017
• Last Update Posted: January 31, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases