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

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

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).

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: Couples-based treatment; Other: Standardized education

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Couples-based treatment- Patient; 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; Couples will attend 3, video based sessions for couples-based treatment
Experimental: Couples-based treatment- Partner; 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; Couples will attend 3, video based sessions for couples-based treatment
Active Comparator: Information Control- Patient; Participants will receive treatment as usual and also standardized information about OSA and CPAP.	Other: Standardized education; Patients will receive standardized educational materials
Active Comparator: Information Control- Partner; Participants will receive treatment as usual and also standardized information about OSA and CPAP.	Other: Standardized education; Patients will receive standardized educational materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Feasibility	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)	study duration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Sleep Disturbance	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.	3 months
Percentage of Days With PAP Use of 4 Hours or More	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).	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention.	3 months
Intervention Completion	Percentage of participants who completed the intervention sessions: 3 sessions for the couples-based treatment group and 1 handout and phone call for the information control group	intervention period, 1 month

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute on Aging (NIA); RAND

Publications and helpful links

General Publications

• Baron KG, Gilles A, Sundar KM, Baucom BRW, Duff K, Troxel W. Rationale and study protocol for We-PAP: a randomized pilot/feasibility trial of a couples-based intervention to promote PAP adherence and sleep health compared to an educational control. Pilot Feasibility Stud. 2022 Aug 6;8(1):171. doi: 10.1186/s40814-022-01089-x.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 13, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: OSA
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 00135927; 1R21AG067183-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon request
• IPD Sharing Time Frame: Within 1 year of completion of the study, will be available for 3 years.
• IPD Sharing Access Criteria: Written request to the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No