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Completed

NCT Number: NCT04759157

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

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).

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Couples-based treatment

Behavioral

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

Standardized education

Other

Patients will receive standardized educational materials

Primary outcomes

  1. Recruitment Feasibility

    Time frame: 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 outcomes

  1. Percentage of Days With PAP Use of 4 Hours or More

    Time frame: 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).

  2. Self-reported Sleep Disturbance

    Time frame: 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.

Other outcomes

  1. Intervention Completion

    Time frame: intervention period, 1 month

    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

  2. Retention

    Time frame: 3 months

    We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institute on Aging (NIA)
  • RAND

Registry information

Official study title

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

Acronym: We-PAP

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 18, 2021
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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