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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Couples-based treatment; Other: Standardized education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04759157

00135927

1R21AG067183-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient and partner inclusion criteria:

1. Age >=50
2. Access to cellular (active data plan) or Wi-Fi, in order to complete the telehealth intervention.

Patients inclusion criteria:

1. Diagnosed with OSA (AHI>10 or AHI>5 with impairment) and intend to start PAP treatment
2. PAP naïve or non-use of PAP for at least 3 years
3. Married or cohabiting with a romantic partner for >1 year
4. Able to read/write English.

Partner inclusion criteria:

1. Able to read/write English
2. 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:

1. High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)
2. History of cognitive or neurological disorders (e.g., dementia, Parkinson's, Multiple Sclerosis)
3. 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)
4. Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe COPD)
5. Use of ASV, VPAP or supplemental oxygen
6. Overnight work > 1x per month
7. Pregnancy/ desire to become pregnant in the study period
8. Current participation in behavioral sleep treatment (e.g., CBT-I) or completion of CBT-I in the past 3 years
9. Concurrent participation in another clinical trial
10. Caregiving for an infant < 2 years old or adult who requires overnight assistance.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 4 patient groups

Couples-based treatment- Patient

Experimental group

Description:

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.

Treatment:

Behavioral: Couples-based treatment

Couples-based treatment- Partner

Experimental group

Description:

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.

Treatment:

Behavioral: Couples-based treatment

Information Control- Patient

Active Comparator group

Description:

Participants will receive treatment as usual and also standardized information about OSA and CPAP.

Treatment:

Other: Standardized education

Information Control- Partner

Active Comparator group

Description:

Participants will receive treatment as usual and also standardized information about OSA and CPAP.

Treatment:

Other: Standardized education