Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAP Adherence Program | Experimental | Manual-based behavioral treatment to improve PAP adherence and sleep. |
|
| Active Control | Active Comparator | Manual-based general sleep education program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAP Adherence Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Nights 1 to 180 following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 following randomization |
| Daytime Sleepiness |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cathy A. Alessi, MD | VA Greater Los Angeles Healthcare System, Sepulveda, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, Sepulveda, CA | Sepulveda | California | 91343 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Active Control | Manual-based general sleep education program provided by supervised allied health personnel. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Post-treatment |
|
| |||||||||||||||||||||
| Six-month Assessment |
| ||||||||||||||||||||||
| 12-month Assessment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Active Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | hours per night | Nights 1 to 180 following randomization |
|
One year following randomization.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mental health distress | Psychiatric disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cathy Alessi | VA Greater Los Angeles Healthcare System | 818 891-7711 | 39311 | cathy.alessi@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2025 | Nov 4, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 6, 2024 | Oct 22, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Neither the participant or staff who conduct the follow-up assessments will be aware of group assignment.
|
| Active Control | Behavioral | 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. |
|
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 following randomization |
| 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 following randomization |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
Manual-based general sleep education program provided by supervised allied health personnel.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Pittsburgh Sleep Quality Index | Scores range from 0 to 21. Higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Epworth Sleepiness Scale | Score range from 0-24. Higher scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Functional Outcomes of Sleep Questionnaire-10 items | Scores range from 5-20. Lower scores indicate worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 6 months following randomization |
|
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 6 months following randomization |
|
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 6 months following randomization |
|
|
|
|
| 1 |
| 53 |
| 6 |
| 53 |
| 0 |
| 53 |
| EG001 | Active Control | Manual-based general sleep education program provided by supervised allied health personnel. | 1 | 53 | 1 | 53 | 0 | 53 |
| Hospitalization | Infections and infestations | Non-systematic Assessment |
|
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization | General disorders | Non-systematic Assessment |
|
| Hospitalization | Renal and urinary disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |