Treating Sleep Apnea in Women Veterans
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sleep Apnea
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Individuals will be assigned to one of two educational programs simultaneouslyMasking: Double (Participant, Outcomes Assessor)Masking Description: Participants and outcome assessors will be blinded to group assignment.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 pop...
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.
Tracking Information
- NCT #
- NCT03377452
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jennifer L Martin, PhD VA Greater Los Angeles Healthcare System, Sepulveda, CA