Possible Efficacy of Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Apnea Syndromes, Obstructive
- Sponsor
- Hillel Yaffe Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- More than 50% improvement in Apnea-Hypopnea index (AHI)
- Last Updated
- 5 years ago
Overview
Brief Summary
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..
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients suffering from OSA, defined as AHI \> 5
Exclusion Criteria
- •Patients who can use CPAP.
- •Patients suffering from confounding factors with higher risk (Coagulation problems, Heart conditions, chronic obstructive pulmonary disease (COPD), or other dangerous conditions as decided by the surgeon)
- •Patients suffering from other problems aggravating the OSA (Respiratory, Neurologic conditions)
Outcomes
Primary Outcomes
More than 50% improvement in Apnea-Hypopnea index (AHI)
Time Frame: 12 months following the procedure
Measuring the AHI score using sleep laboratory
Reduction of AHI to below 20
Time Frame: 12 months following the procedure
Measuring the AHI score using sleep laboratory