Salt Lake City, Utah 84108

  • Obstructive Sleep Apnea

Purpose:

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 summary:

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.


Criteria:

Inclusion Criteria: Patient and partner inclusion criteria: 1. Age >=50 2. Couple shares a bed> 3 nights per week or desire to return to sharing a bed 3. 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 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 >60) 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.


NCT ID:

NCT04759157


Primary Contact:

Kelly Baron, Ph.D.
Phone: 8015857588
Email: kelly.baron@utah.edu


Backup Contact:

Email: giulia.devettori@utah.edu
Giulia De Vettori
Phone: 8015857588


Location Contact:

Salt Lake City, Utah 84108
United States

Giulia DeVettori
Phone: 801-585-7588
Email: giulia.devettori@utah.edu

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 16, 2021

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