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The objectives of this study is to compare short-term outcomes of CPAP and Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 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 Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 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 2 weeks and Wash-out periods 2 weeks are required before start each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP Therapy | Active Comparator | Continuous Positive Airway Pressure |
|
| Somnoguard | Experimental | Somnoguard |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | CPAP is used for 6 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | FOSQ scores | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| side effects | questionnaires | 6 weeks |
| satisfaction | VAS scores | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wish Banhiran, MD | Contact | 6699756405 | wishbanh@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wish Banhiran, MD | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Recruiting | Bangkok | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28714534 | Derived | Banhiran W, Assanasen P, Nopmaneejumrudlers C, Nujchanart N, Srechareon W, Chongkolwatana C, Metheetrairut C. Adjustable thermoplastic oral appliance versus positive airway pressure for obstructive sleep apnea. Laryngoscope. 2018 Feb;128(2):516-522. doi: 10.1002/lary.26753. Epub 2017 Jul 17. |
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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 |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Somnoguard | Device | Somnoguard is used for 6 weeks |
|
| AHI |
Apnea-hypopnea index (events per hour) |
| 6 weeks |
| Degree of sleepiness | ESS scores | 6 weeks |
| lowest oxygen saturation | lowest oxygen saturation (%) | 6 weeks |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |