Tailored Intervention to Promote Positive Airway Pressure Adherence

Phase 1

Completed

Brief Summary: The purpose of this study is to examine the feasibility of a tailored (i.e., individualized) intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.

Detailed Description: Poor adherence to CPAP is a significant problem among OSA patients resulting in suboptimal health and functional outcomes. Intervention studies to promote CPAP adherence have shown relatively small effects in selected samples and were costly. The overall objective of this research is to examine the effect, feasibility, and acceptability of a tailored intervention on CPAP adherence among adults with newly-diagnosed, CPAP treated OSA. The central hypothesis is that critically timed tailored interventions that focus on sociocultural aspects and cognitive perceptions of the individual experience with OSA diagnosis and treatment will improve overall CPAP adherence rates. The pilot randomized controlled trial will examine CPAP adherence outcomes at 1wk, 1mo, and 3mo among those randomly assigned to the tailored intervention or usual (standard) care and examine specific feasibility and participant acceptability outcomes in order to design and conduct a subsequent larger randomized controlled trial testing the overall efficacy of the tailored intervention.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

previous diagnosis and/or treatment of OSA
major new psychiatric diagnosis within 6 months of study enrollment
require supplemental oxygen or bilevel positive airway pressure on CPAP titration polysomnogram
diagnosis of co-existent sleep disorder on polysomnogram, including periodic limb movements >/= 10 events/hr with arousal, central sleep apnea with >/= 5 central events/hr, insomnia, sleep hypoventilation syndrome, or narcolepsy

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Tailored	Tailored	Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions

Primary Outcome Measures

Name	Time	Method
Nightly CPAP Use	3 months	Mean CPAP use, hrs/night

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Who Complete Protocol After Allocation	Duration of protocol period	Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT
Acceptability of Study Intervention and Comparative Group	3 months	Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to "interview" at study termination and debriefing (3 months)
Proportion of Sleep Time on CPAP	1 week	% of Total Sleep Time (TST) using CPAP
Proportion of Participants Who Withdrawal	Duration of protocol period	Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT