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Obstructive Sleep apnea carries a variety of complications and implications. While the disease could be treated using continuous positive airway pressure (CPAP) and lifestyle changes, many patients find it difficult to adjust to the mask, and turn to surgical options. The conventional surgical options to date ranges from radical (UPPP) to individualized, with or without Drug-induced sleep endoscopy (DISE). Previous studies showed that dise directed surgery can be useful for specific conditions. No trials were found to test in-office encompassing minimal invasive surgical treatment (RF palatoplasty , RF tonsillotomy, RF turbinectomy, and RF base-of-tongue reduction) as a viable alternative..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Patient suffering from OSA, and found to suffer from obstruction of one or more of the following areas - Lower turbines, Soft Palate, Tonsils, Base-of-tongue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive, in-office, RF reduction of the affected area | Procedure | Usage of RF needle to treat one or more of the affected areas |
|
| Measure | Description | Time Frame |
|---|---|---|
| More than 50% improvement in Apnea-Hypopnea index (AHI) | Measuring the AHI score using sleep laboratory | 6 months following the procedure |
| More than 50% improvement in Apnea-Hypopnea index (AHI) | Measuring the AHI score using sleep laboratory | 12 months following the procedure |
| Reduction of AHI to below 20 | Measuring the AHI score using sleep laboratory | 6 months following the procedure |
| Reduction of AHI to below 20 | Measuring the AHI score using sleep laboratory | 12 months following the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Itzhak Braverman, MD | Contact | 972-4-7744664 | braverman@hy.health.gov.il | |
| Isaac Shochat, MD | Contact | 972-4-7744664 | isaacs@hy.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillel Yaffe MC, | Recruiting | Hadera | 38100 | Israel |
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| 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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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |