Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Nightly CPAP Use
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •males and females >/= 18 years of age
- •newly diagnosed with apnea/hypopnea index >/= 10 events/hr
- •CPAP naive
- •able to read and speak English
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
Arms & Interventions
Tailored
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
Intervention: Tailored (Behavioral)
Usual care
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
Nightly CPAP Use
Time Frame: 3 months
Mean CPAP use, hrs/night
Nightly CPAP Use
Time Frame: 1 week
Mean CPAP use, hrs/night
Nightly CPAP Use
Time Frame: 1 month
Mean CPAP use, hrs/night
Secondary Outcomes
- Proportion of Participants Who Complete Protocol After Allocation(Duration of protocol period)
- Acceptability of Study Intervention and Comparative Group(3 months)
- Proportion of Sleep Time on CPAP(1 week)
- Proportion of Participants Who Withdrawal(Duration of protocol period)
Investigators
Amy M. Sawyer
Assistant Professor
Milton S. Hershey Medical Center