Treatment Adherence and Outcomes in Three Modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea

Study Overview
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Brief Summary
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The purpose of this study is to compare the treatment adherence and effects in three modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea.

Detailed Description
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Obstructive sleep apnea (OSA) is a common disorder that is associated with substantial morbidity, including excessive daytime sleepiness, hypertension, and cardiovascular disease. Although Continuous Pressure Airway Pressure (CPAP) is effective treatment of objective and subjective complaints, adherence to CPAP therapy is suboptimal. Recently, pressure-relief CPAP (C-flex,A-flex; Respironics; Murrysville, PA) is available. The present study is single-blind,prospective, randomised, crossover study to compare the adherence and effects of therapy with C-flex, A-flex, and autoadjusting CPAP after 3 months of CPAP treatment. Additionally, after 3 months of CPAP treatment, the patients who treated with C-flex and A-flex will crossovered, we will acess to change of adherence and effects of CPAP treatment.

Official Title
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Comparison of Three Modalities of Continuous Positive Pressure Airway Treatment for Obstructive Sleep Apnea Syndrome

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: CPAP (REMstar (Respironics))


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital. Subjects diagnosed with OSA (apnea hypopnea index >=5/hour) by overnight polysomnography. Exclusion Criteria: Subjects diagnosed with CSA by overnight polysomnography. Subjects ever used CPAP for OSA.

Ages Eligible for Study
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Minimum Age: 20 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C-flex<br> | Device: CPAP (REMstar (Respironics))<br>* Pressure-relief CPAP treatment may reduce the sensation of breathing against high pressure without causing the upper airways to collapse and improve adherence.<br>* Other names: REMstar (Respironics);|
| Active Comparator: A-flex<br> | Device: CPAP (REMstar (Respironics))<br>* Pressure-relief CPAP treatment may reduce the sensation of breathing against high pressure without causing the upper airways to collapse and improve adherence.<br>* Other names: REMstar (Respironics);|
| No Intervention: Auto-CPAP<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective, objective satisfaction and complaints for CPAP therapy |  | 3 months | 
| respiratory events (ie. apnea-hypopnea index) |  | 3 months | 
| change of positive airway pressure |  | 3 months | 
| quality of life etc. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Continuous Positive Airway Pressure