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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-flex | Active Comparator |
| |
| A-flex | Active Comparator |
| |
| Auto-CPAP | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP (REMstar (Respironics)) | Device | Pressure-relief CPAP treatment may reduce the sensation of breathing against high pressure without causing the upper airways to collapse and improve adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.) | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazuo Chin, MD,PhD | Kyoto University, Graduate School of Medicine | Principal Investigator |
| Yuichi Chihara, MD,PhD | Kyoto University, Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto University Graduate School of Medicine | Kyoto | Kyoto | 6068507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23372270 | Derived | Chihara Y, Tsuboi T, Hitomi T, Azuma M, Murase K, Toyama Y, Harada Y, Aihara K, Tanizawa K, Handa T, Yoshimura C, Oga T, Yamamoto K, Mishima M, Chin K. Flexible positive airway pressure improves treatment adherence compared with auto-adjusting PAP. Sleep. 2013 Feb 1;36(2):229-36. doi: 10.5665/sleep.2378. |
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|
| 3 months |
| quality of life etc. | 3 months |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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