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

Obstructive Sleep Apnea Clinical Trial

— We-PAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759157
• Other study ID #: 00135927
• Secondary ID: 1R21AG067183-01A
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 31, 2023
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Couples-based treatment
Couples will attend 3, video based sessions for couples-based treatment

Other:
• Standardized education
Patients will receive standardized educational materials

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	National Institute on Aging (NIA), RAND

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship satisfaction	Patient and partner relationship quality will be measured via self-report	1 and 3 months
Other	Cognitive functioning	Patient and partner change in cognitive functioning will be measured using the RBANS instrument	3 months
Primary	Hours of CPAP use	Patient adherence to CPAP will be measured via download of their machine	3 months
Secondary	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
Secondary	Objective sleep	Patient and partner objective sleep quality will be measured using actigraphy at baseline, 1 and 3 months	1 month and 3 months