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Treating Sleep Apnea in Women Veterans

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ClinicalTrials.gov Identifier: NCT03377452
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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 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
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377452


Contacts
Contact: Jennifer 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 Not yet recruiting
Sepulveda, California, United States, 91343
Contact: Dean T Yamaguchi, MD    310-268-4437    Dean.Yamaguchi@va.gov   
Contact: Mark Hori, BS    (818) 895-9416    Mark.Hori@va.gov   
Principal Investigator: Jennifer Martin, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Jennifer Martin, PhD VA Greater Los Angeles Healthcare System, Sepulveda, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03377452     History of Changes
Other Study ID Numbers: IIR 16-244
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
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
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases