Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Sleep Apnea
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Masking Description: Neither the participant or staff who conduct the follow-up assessments will be aware of group assignment.Primary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 125 years
Gender
Both males and females

Description

Background: The most frequently diagnosed sleep disorder among middle-aged and older Veterans is obstructive sleep apnea (OSA), which is associated with serious adverse effects on health, quality of life and survival. Positive airway pressure (PAP) is recommended as first-line treatment (particularl...

Background: The most frequently diagnosed sleep disorder among middle-aged and older Veterans is obstructive sleep apnea (OSA), which is associated with serious adverse effects on health, quality of life and survival. Positive airway pressure (PAP) is recommended as first-line treatment (particularly for moderate to severe OSA), but sustained use is difficult to achieve, including among middle-aged and older Veterans, and nearly half of patients with OSA who begin PAP therapy discontinue use within a year. Significance/Impact: Although OSA is a chronic condition, research to date has primarily focused on increasing initial PAP use in patients with newly diagnosed OSA. In addition, most research has not addressed PAP use in older adults, which is unfortunate given the high prevalence and important adverse effects of OSA on their health and well-being. Prior work suggests that behavioral interventions are effective in improving initial PAP use, but little is known of how to address insufficient PAP use over time. Innovation: To address this problem, the investigators developed and pilot-tested a structured, manual-based approach to address insufficient PAP use among middle-aged and older adults with previously diagnosed OSA. The intervention (5 sessions over 8 weeks, then monthly contact for up to 6 months) is designed so it can be provided by individuals ("sleep coaches") from various disciplines (supervised remotely by a psychologist) in a variety of settings for maximal implementation. Specific Aims: Primary Aim 1 will test the efficacy of this intervention for improving PAP usage among middle-aged and older Veterans with previously diagnosed OSA who have insufficient PAP use. The hypotheses are that the intervention will increase objectively measured PAP use at 6-months follow-up, with effects sustained at 12 months. Secondary Aim 2 will test for effects on sleep quality, daytime sleepiness and sleep-related function; and Exploratory Aim 3 will test for effects on health-related quality of life. The hypotheses are that these outcomes will also improve at 6 months, and effects will be sustained at 12 months. Methodology: The investigators are conducting a randomized, controlled trial to test this new intervention in middle-aged and older Veterans (N=90) with previously diagnosed OSA (moderate to severe) who were prescribed PAP, but have insufficient PAP use (defined as no PAP use over the prior 30 days). Participants will be randomized to one of two groups. Structured assessments at baseline, post-treatment (after session 5) and 6- and 12-months follow-up include objectively measured PAP use (via remote telemonitoring), sleep quality, daytime sleepiness, sleep-related function and health-related quality of life. The investigators will also collect participant experiences and attitudes related to the intervention, and implementation outcome measures (acceptability, appropriateness, fidelity and staff time as an estimate of cost) to inform future implementation. Implementation/Next Steps: The long-term goal of this work is to effectively address insufficient PAP use among middle-aged and older Veterans with OSA to improve their sleep and quality of life. If successful, the investigators will implement the intervention at the investigators' institution, and develop and disseminate an implementation package with actual tools needed to promote wider implementation of this model of care into clinical practice.

Tracking Information

NCT #
NCT04868682
Collaborators
Not Provided
Investigators
Principal Investigator: Cathy A Alessi, MD VA Greater Los Angeles Healthcare System, Sepulveda, CA