Status:
COMPLETED
We-PAP: A Couples-based Intervention for Sleep Apnea
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Institute on Aging (NIA)
RAND
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
50-85 years
Phase:
NA
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 an...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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.
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04759157
Start Date
June 16 2021
End Date
January 31 2023
Last Update
December 10 2024
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84108