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Treating Sleep Apnea in Women Veterans

Primary Purpose

Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Education Intervention I
Behavioral Education Intervention II
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • VA Greater Los Angeles Healthcare System, Sepulveda, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Behavioral Education Intervention I

Behavioral Education Intervention II

Arm Description

Manual-based education program focusing on sleep and sleep apnea provided in individual sessions.

Manual-based education program focusing on sleep and sleep apnea provided in individual sessions.

Outcomes

Primary Outcome Measures

PAP adherence
Percent of nights with 4 or more hours of PAP use.
sleep quality by patient-reported sleep questionnaire
Self-reported sleep quality assessed with a brief patient questionnaire assessing multiple aspects of sleep quality.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2017
Last Updated
December 13, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03377452
Brief Title
Treating Sleep Apnea in Women Veterans
Official Title
Diagnosis and Treatment of Sleep Apnea in Women Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals will be assigned to one of two educational programs simultaneously
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and outcome assessors will be blinded to group assignment.
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Education Intervention I
Arm Type
Experimental
Arm Description
Manual-based education program focusing on sleep and sleep apnea provided in individual sessions.
Arm Title
Behavioral Education Intervention II
Arm Type
Experimental
Arm Description
Manual-based education program focusing on sleep and sleep apnea provided in individual sessions.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Education Intervention I
Intervention Description
Manual-based education program focusing on sleep and sleep apnea provided in individual sessions.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Education Intervention II
Intervention Description
Manual-based education program focusing on sleep and sleep apnea provided in individual sessions.
Primary Outcome Measure Information:
Title
PAP adherence
Description
Percent of nights with 4 or more hours of PAP use.
Time Frame
3 months after PAP initiation
Title
sleep quality by patient-reported sleep questionnaire
Description
Self-reported sleep quality assessed with a brief patient questionnaire assessing multiple aspects of sleep quality.
Time Frame
3 months from randomization

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is for women Veterans.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Martin, PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, Sepulveda, CA
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Treating Sleep Apnea in Women Veterans

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