N/A
Completed N=74
We-PAP: A Couples-based Intervention for Sleep Apnea
Source: ClinicalTrials.gov NCT04759157 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Recruitment Feasibility — 42; 42 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Feasibility |
42; 42 | — |
| SECONDARY Percentage of Days With PAP Use of 4 Hours or More |
.73; .72 | .30 |
| SECONDARY Self-reported Sleep Disturbance |
55.3; 50.6; 56.7; 48.6; 49.6; 48.3 | .206 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04759157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.