Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.

Detailed Description
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Poor treatment adherence with CPAP therapy is well-documented. Set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial-Usual Care patients (control) versus i-PAP patients (intervention). An important empirical-methodological advantage of the project is the objective measurement of CPAP adherence, which is measured by internal microprocessor as the amount of time CPAP is used at the prescribed pressure. This objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-PAP intervention was designed around this central feature.

Official Title
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Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Conditions
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Sleep Apnea Syndromes

Intervention / Treatment
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* Behavioral: i-PAP
* Behavioral: Usual Care (Standard Care)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years confirmed diagnosis of OSA being newly prescribed CPAP therapy having chronic symptoms as noted on screening symptom checklist fluency in English Exclusion Criteria: cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30) residence in a geographical area outside of San Diego County fatal comorbidity (life expectancy less than 6 months as indicated by treating physician) significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: i-PAP<br>* Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care<br>|
| Active Comparator: 2<br>Usual Care (Standard Care) | Behavioral: Usual Care (Standard Care)<br>* Pre-determined clinic visits and telephone support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP Adherence |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of patient-centered collaborative care |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Sleep Apnea, Sleep Apnea, Sleep Apnea Treatment