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N/A Completed N=74 Randomized Double-blind Other

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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