A Novel Couples- Based Sleep Health Intervention For Older Adults With Obstructive Sleep Apnea: Implications for Alzheimer's Disease Risk And Healthy Aging
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- University of Utah
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Recruitment Feasibility
- Status
- Completed
- Last Updated
- last year
Overview
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 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.
Investigators
Kelly Glazer Baron
Associate Professor
University of Utah
Eligibility Criteria
Inclusion Criteria
- •Patient and partner inclusion criteria:
- •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
Outcomes
Primary Outcomes
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
- Percentage of Days With PAP Use of 4 Hours or More(3 months)
- Self-reported Sleep Disturbance(3 months)