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

Not Applicable

Completed

Interventions: Other: Standardized education
Behavioral: Couples-based treatment

Brief Summary: 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: 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.

Recruitment & Eligibility

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:

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.

Arm && Interventions

Group	Intervention	Description
Standard Information Control	Standardized education	Participants will receive treatment as usual and also standardized information about OSA and CPAP.
Couples-based treatment	Couples-based treatment	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.

Primary Outcome Measures

Name	Time	Method
Recruitment Feasibility	study duration	Defined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period (12 months)

Secondary Outcome Measures

Name	Time	Method
Percentage of Days With PAP Use of 4 Hours or More	3 months	The primary efficacy measure for this pilot trial was the percentage of days that patients used CPAP for 4 hours or more over the first 3 months. This 4 hour cutoff was selected becasue it is the minimum usage defined by Medicare and other insurance companies. We obtained patients' CPAP usage by downloading data from their machine using a remote dashboard. Data are only available for patients because partners were not using the treatment. This variable is defined as a proportion, calculated as the number of days with CPAP usage of 4 hours or more divided by the total number of days collected in the 3 month recording period. Scores can range from 0 (no days with use to 1, indicating all days with use of 4 hours or more).
Self-reported Sleep Disturbance	3 months	Patient sleep quality on the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance scale, 8 item, version 8b. Models evaluated change from baseline to 3 months. Raw are converted to t-scores, with a range of 28.9-76.5, a mean of 50 and a SD of 10. Higher scores indicate poorer sleep subjective quality.