Tailored Intervention to Promote Positive Airway Pressure Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence

Conditions
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Sleep Apnea, Obstructive, Patient Compliance

Intervention / Treatment
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* Behavioral: Tailored
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored<br>Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions | Behavioral: Tailored<br>* 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<br>* Other names: Individualized;|
| Active Comparator: Usual care<br>The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment | Other: Usual care<br>* 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<br>* Other names: standard of care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nightly CPAP Use | Mean CPAP use, hrs/night | 1 week | 
| Nightly CPAP Use | Mean CPAP use, hrs/night | 1 month | 
| Nightly CPAP Use | Mean CPAP use, hrs/night | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Sleep Time on CPAP | % of Total Sleep Time (TST) using CPAP | 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 | Duration of protocol period | 
| Proportion of Participants Who Withdrawal | Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT | 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) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social support, Cognition, Adaptation, psychological, Health behavior, Patient education