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Addressing Insufficient PAP Use in Older Veterans

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04868682
Enrollment
106
Registered
2021-05-03
Start date
2022-01-10
Completion date
2025-09-30
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

sleep apnea, positive airway pressure

Brief summary

Obstructive sleep apnea (OSA) is a common problem among 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 OSA 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 behavioral treatment 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 groups. Both groups will meet individually with a sleep coach for 5 session over 8 weeks, then they will be contacted by the sleep coach 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 with OSA.

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 behavioral treatment to address insufficient PAP use among middle-aged and older adults with previously diagnosed OSA. The intervention (5 individual virtual sessions over 8 weeks, then monthly brief telephone 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 moderate or severe OSA who have insufficient PAP use. The hypotheses are that the intervention will increase objectively measured PAP use over 6-months follow-up, with effects sustained over 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=106) with previously diagnosed OSA (moderate or 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 (e.g., 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 develop an implementation package to promote wider implementation of this model of care into clinical practice.

Interventions

BEHAVIORALPAP Adherence Program

Manual-based treatment focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep. The intervention involves five individual virtual sessions provided by allied health personnel, with brief monthly telephone contact for up to 6 months. Allied health personnel have regular supervision with a behavioral sleep medicine psychologist.

BEHAVIORALActive Control

Manual-based general sleep education program. The active control involves five individual virtual sessions provided by allied health personnel, with brief monthly telephone contact for up to 6 months. Allied health personnel have regular supervision with a study clinician.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Neither the participant or staff who conduct the follow-up assessments will be aware of group assignment.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PAP AdherenceNights 1 to 180 following randomizationMean hours of PAP use per night calculated for nights 1 to 180 (night 1 is the first night after randomization). Higher numbers indicate a better outcome.

Secondary

MeasureTime frameDescription
Sleep Quality6 months following randomizationTotal 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 Sleepiness6 months following randomizationTotal 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 Function6 months following randomizationTotal 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
PAP Adherence Program
Manual-based program provided by supervised allied health personnel focused on PAP adherence with behavioral strategies to improve PAP adherence and sleep.
53
Active Control
Manual-based general sleep education program provided by supervised allied health personnel.
53
Total106

Withdrawals & dropouts

PeriodReasonFG000FG001
12-month AssessmentDeath01
12-month AssessmentLost to Follow-up21
Post-treatment1 refused assessment; 1 in residing in a nursing home; 1 assessment was missed by staff12
Post-treatmentLost to Follow-up11
Six-month AssessmentDeath10
Six-month AssessmentLost to Follow-up10
Six-month AssessmentRefused01

Baseline characteristics

CharacteristicActive ControlPAP Adherence ProgramTotal
Age, Continuous65.5 years
STANDARD_DEVIATION 9.1
67.1 years
STANDARD_DEVIATION 9.7
66.3 years
STANDARD_DEVIATION 9.4
Epworth Sleepiness Scale8.3 units on a scale
STANDARD_DEVIATION 4.9
9.5 units on a scale
STANDARD_DEVIATION 5.4
8.9 units on a scale
STANDARD_DEVIATION 5.2
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants9 Participants25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
37 Participants44 Participants81 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Functional Outcomes of Sleep Questionnaire-10 items14.9 units on a scale
STANDARD_DEVIATION 3.7
14.0 units on a scale
STANDARD_DEVIATION 3.5
14.4 units on a scale
STANDARD_DEVIATION 3.6
Pittsburgh Sleep Quality Index9.9 units on a scale
STANDARD_DEVIATION 4.1
10.4 units on a scale
STANDARD_DEVIATION 4.5
10.2 units on a scale
STANDARD_DEVIATION 4.3
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
17 Participants21 Participants38 Participants
Race (NIH/OMB)
More than one race
4 Participants4 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants3 Participants7 Participants
Race (NIH/OMB)
White
25 Participants22 Participants47 Participants
Sex: Female, Male
Female
5 Participants7 Participants12 Participants
Sex: Female, Male
Male
48 Participants46 Participants94 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 531 / 53
other
Total, other adverse events
0 / 530 / 53
serious
Total, serious adverse events
6 / 531 / 53

Outcome results

Primary

PAP Adherence

Mean hours of PAP use per night calculated for nights 1 to 180 (night 1 is the first night after randomization). Higher numbers indicate a better outcome.

Time frame: Nights 1 to 180 following randomization

ArmMeasureValue (MEAN)Dispersion
PAP Adherence ProgramPAP Adherence2.16 hours per nightStandard Error 0.26
Active ControlPAP Adherence0.87 hours per nightStandard Error 0.19
p-value: 0.000195% CI: [0.65, 1.91]t-test, 2 sided
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.

Time frame: 6 months following randomization

ArmMeasureValue (MEAN)Dispersion
PAP Adherence ProgramDaytime Sleepiness6.11 score on a scaleStandard Error 0.67
Active ControlDaytime Sleepiness7.59 score on a scaleStandard Error 0.67
p-value: <0.00195% CI: [-4.09, -1.27]Mixed Models Analysis
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.

Time frame: 6 months following randomization

ArmMeasureValue (MEAN)Dispersion
PAP Adherence ProgramSleep Quality7.72 score on a scaleStandard Error 0.6
Active ControlSleep Quality8.01 score on a scaleStandard Error 0.59
p-value: 0.37895% CI: [-2.29, 0.87]Mixed Models Analysis
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.

Time frame: 6 months following randomization

ArmMeasureValue (MEAN)Dispersion
PAP Adherence ProgramSleep-related Function14.65 score on a scaleStandard Error 0.5
Active ControlSleep-related Function15.67 score on a scaleStandard Error 0.5
p-value: 0.86595% CI: [-1.4, 1.18]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026