Addressing Insufficient PAP Use in Older Veterans
Primary Purpose
Sleep Apnea
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Education Intervention I
Behavioral Education Intervention II
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring sleep apnea, positive airway pressure
Eligibility Criteria
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
Sites / Locations
- VA Greater Los Angeles Healthcare System, Sepulveda, CARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Behavioral Education Intervention I
Behavioral Education Intervention II
Arm Description
Manual-based education program provided in individual sessions
Manual-based education program provided in individual sessions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04868682
First Posted
April 26, 2021
Last Updated
January 19, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04868682
Brief Title
Addressing Insufficient PAP Use in Older Veterans
Official Title
Addressing Insufficient Positive Airway Pressure Use Among Older Veterans With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
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
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
sleep apnea, positive airway pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Neither the participant or staff who conduct the follow-up assessments will be aware of group assignment.
Allocation
Randomized
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Education Intervention I
Arm Type
Experimental
Arm Description
Manual-based education program provided in individual sessions
Arm Title
Behavioral Education Intervention II
Arm Type
Active Comparator
Arm Description
Manual-based education program provided in individual sessions
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Education Intervention I
Intervention Description
Manual-based education program provided in individual sessions.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Education Intervention II
Intervention Description
Manual-based education program provided in individual sessions.
Primary Outcome Measure Information:
Title
PAP adherence
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Sleep quality
Description
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.
Time Frame
6 months
Title
Daytime sleepiness
Description
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.
Time Frame
6 months
Title
Sleep-related function
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy A Alessi, MD
Phone
(818) 891-7711
Ext
36070
Email
cathy.alessi@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Karen J Camacho, MPH
Phone
(818) 891-7711
Ext
36083
Email
Karen.Camacho@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy A Alessi, MD
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael K Ong, MD PhD
Phone
310-478-3711
Ext
42345
Email
Michael.Ong2@va.gov
First Name & Middle Initial & Last Name & Degree
Scott E Krahl, PhD MA BA
Phone
(818) 895-5861
Email
scott.krahl@va.gov
First Name & Middle Initial & Last Name & Degree
Cathy A Alessi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Addressing Insufficient PAP Use in Older Veterans
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