We-PAP: A Couples-based Intervention for Sleep Apnea

Study Overview
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Brief Summary
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The purpose of this study is to develop, refine and evaluate the feasibility of a novel couples-based intervention to improve adherence for patients with obstructive sleep apnea (OSA).

Detailed Description
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This study will develop and test a novel couples-based intervention for the treatment of OSA and sleep health among older couples. The focus of this study is patient who are starting CPAP treatment and their partners. Couples will be randomized to a 3-session sleep health intervention delivered via telehealth or to standard educational support for CPAP. The intervention is based on a transdiagnostic model of sleep and circadian disorders (TransS-C) and rooted in the idea that older adults with OSA are often also having other sleep problems, and that OSA is best treated in the couples context.

Official Title
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A Novel Couples- Based Sleep Health Intervention For Older Adults With Obstructive Sleep Apnea: Implications for Alzheimer's Disease Risk And Healthy Aging

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Couples-based treatment
* Other: Standardized education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient and partner inclusion criteria: Age >=50 Access to cellular (active data plan) or Wi-Fi, in order to complete the telehealth intervention. Patients inclusion criteria: Diagnosed with OSA (AHI>10 or AHI>5 with impairment) and intend to start PAP treatment PAP naïve or non-use of PAP for at least 3 years Married or cohabiting with a romantic partner for >1 year Able to read/write English. Partner inclusion criteria: Able to read/write English PROMIS sleep disturbance score >55 in either patient or partner, or desire to improve sleep. Exclusion Criteria: Patient only exclusion criteria: 1. Concomitant OSA treatments (bariatric surgery planned in the next 3 months or bariatric surgery in the past year, ear nose and throat surgery for sleep apnea occurring in the 3 months before or planning for within the study period). Exclusion criteria for both patient and partner include the following: High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome) History of cognitive or neurological disorders (e.g., dementia, Parkinson's, Multiple Sclerosis) Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder), alcohol abuse reported on the Audit-C (score >4 for men, >3 for women), drug use (NIDA-Modified ASSIST score >3) Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe COPD) Use of ASV, VPAP or supplemental oxygen Overnight work > 1x per month Pregnancy/ desire to become pregnant in the study period Current participation in behavioral sleep treatment (e.g., CBT-I) or completion of CBT-I in the past 3 years Concurrent participation in another clinical trial Caregiving for an infant < 2 years old or adult who requires overnight assistance.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Couples-based treatment<br>Participants will attend 3, sessions (75, 50, 50 min) over video with a study therapist to discuss education about OSA and CPAP, strategies adjust to CPAP as a couple and techniques to improve sleep health. | Behavioral: Couples-based treatment<br>* Couples will attend 3, video based sessions for couples-based treatment<br>|
| Other: Standard Information Control<br>Participants will receive treatment as usual and also standardized information about OSA and CPAP. | Other: Standardized education<br>* Patients will receive standardized educational materials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hours of CPAP use | Patient adherence to CPAP will be measured via download of their machine | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported sleep | Patient and partner self-reported sleep quality will be measured using the PROMIS sleep disturbance measure at baseline, 1 and 3 months | 1 and 3 months | 
| Objective sleep | Patient and partner objective sleep quality will be measured using actigraphy at baseline, 1 and 3 months | 1 month and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA