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NCT04759157 | COMPLETED | Obstructive Sleep Apnea

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

University of Utah

Information provided by (Responsible Party):

Kelly Glazer Baron

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).

Condition or disease

Obstructive Sleep Apnea

Intervention/treatment

Couples-based treatment

Standardized education

Phase

NA

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
Estimated Enrollment : 84 participants
Masking : DOUBLE
Masking Description : Investigators and outcomes assessors will not have knowledge of the randomization table. Participants will be reminded to not to tell the outcomes assessors their group. Only the statistician and interventionist will be aware of the group.
Primary Purpose : OTHER
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
Actual Study Start Date : 2020-03-01
Estimated Primary Completion Date : 2022-12-16
Estimated Study Completion Date : 2023-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
We-PAP: A Couples-based Intervention for Sleep Apnea

Location Details

NCT04759157

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84108