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The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively.
The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively. Wash-in period 1 week and Wash-out periods 1 week are required before start each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP1 use and TRD 2use | Active Comparator | Wash-in period 1 week and Continuous positive airway pressure (CPAP) is used for 3 weeks then wash-out 1 week and Tongue retaining device (TRD) is used for another 3 weeks |
|
| TRD1 use and CPAP2 use | Experimental | Wash-in period 1 week and Tongue retaining device (TRD) is used for 3 weeks then Wash-out period 1 week and Continuous positive airway pressure (CPAP) is used for another 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tongue retaining device | Device | Tongue retaining device is used for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| apnea-hypopnea index (AHI) | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcomes of sleep questionnaire (FOSQ ) score | 3 weeks | |
| Epworth sleepiness score (ESS) scores | 3 weeks | |
| lowest oxygen saturation during sleep test at home |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wish - Banhiran, MD | Contact | 6699756405 | wishbanh@hotmail.com | |
| Anuch - Durongphan, MD | Contact | 662 419 8040 | anuch.mai@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Anuch - Durongphan, MD | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Recruiting | Bangkoknoi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31754961 | Derived | Banhiran W, Durongphan A, Keskool P, Chongkolwatana C, Metheetrairut C. Randomized crossover study of tongue-retaining device and positive airway pressure for obstructive sleep apnea. Sleep Breath. 2020 Sep;24(3):1011-1018. doi: 10.1007/s11325-019-01942-z. Epub 2019 Nov 21. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 6, 2017 | |
| Reset | Mar 24, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 6, 2017 | Mar 24, 2017 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract 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 |
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| CPAP | Device | CPAP is used for 3 weeks |
|
|
| 3 weeks |
| side effects questionnaire | 3 weeks |
| satisfaction and preference of device questionnaire | 3 weeks |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |