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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
118
Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Nightly CPAP Use
Mean CPAP use, hrs/night
Time frame: 1 week
Nightly CPAP Use
Mean CPAP use, hrs/night
Time frame: 1 month
Nightly CPAP Use
Mean CPAP use, hrs/night
Time frame: 3 months
Proportion of Sleep Time on CPAP
% of Total Sleep Time (TST) using CPAP
Time frame: 1 week
Proportion of Participants Who Complete Protocol After Allocation
Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT
Time frame: Duration of protocol period
Proportion of Participants Who Withdrawal
Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT
Time frame: Duration of protocol period
Acceptability of Study Intervention and Comparative Group
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)
Time frame: 3 months
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