Addressing Insufficient PAP Use in Older Veterans

Sleep Apnea Clinical Trial

Official title:

Addressing Insufficient Positive Airway Pressure Use Among Older Veterans With Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868682
• Other study ID #: IIR 20-046
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Cathy A Alessi, MD MPH
• Phone: (818) 891-7711
• Email: cathy.alessi[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sleep apnea is a common problem in middle-aged and older Veterans that is associated with poor nighttime sleep, more daytime sleepiness, poor functioning and worse quality of life. The recommended therapy for most patients with sleep apnea is positive airway pressure (PAP) therapy; however, over time many patients prescribed PAP therapy no longer use it regularly. This study will test the effects of an education program specifically designed for middle-aged and older Veterans who have stopped using their PAP device, or are not using it regularly.

Eligible Veterans who are enrolled into the study will receive a baseline assessment that includes questionnaires about sleep, health, and quality of life. After completing the baseline assessment, participants will be randomly assigned to one of two education groups. Both groups will meet individually with a "sleep coach" for 5 session over 8 weeks, then they will be contacted monthly by telephone for up to 6 months. Participants will complete follow-up assessments immediately after the fifth education session and again at 6-months and 12-months.

If successful, this approach has the potential to improve sleep, function and quality of life in middle-aged and older Veterans.

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 (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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of moderate to severe obstructive sleep apnea (apnea hypopnea index [AHI] > or = 15)

• Previously prescribed positive airway pressure (PAP) therapy

• Insufficient PAP use (defined as no PAP use over the past 30 days)

Exclusion Criteria:

• Severe psychopathology (e.g., active psychosis) that precludes participation in the study

• Severe unstable medical illness that precludes participation in the study

• Significant cognitive impairment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Behavioral:
• Behavioral Education Intervention I
Manual-based education program provided in individual sessions.
• Behavioral Education Intervention II
Manual-based education program provided in individual sessions.

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAP adherence	Mean hours of PAP use per night calculated for the first 30 days of use and then each subsequent 30 day period over the 6-month follow-up period.	6 months
Secondary	Sleep quality	Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21.; Higher scores indicate worse outcome.	6 months
Secondary	Daytime sleepiness	Total score on the Epworth Sleepiness Scale will be used as a measure of daytime sleepiness. Score range from 0-24. Higher scores indicate worse outcome.	6 months
Secondary	Sleep-related function	Total score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10) will be used as a measure of sleep-related function. Scores range from 5-20. Lower scores indicate worse outcome.	6 months