Sleep Apnea Syndromes, Obstructive
Conditions
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..
Interventions
PROCEDUREMinimally invasive, in-office, RF reduction of the affected area
Usage of RF needle to treat one or more of the affected areas
Sponsors
Hillel Yaffe Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| More than 50% improvement in Apnea-Hypopnea index (AHI) | 6 months following the procedure | Measuring the AHI score using sleep laboratory |
| Reduction of AHI to below 20 | 6 months following the procedure | Measuring the AHI score using sleep laboratory |
Countries
Israel
Contacts
Primary ContactItzhak Braverman, MD
Backup ContactIsaac Shochat, MD
Outcome results
None listed