Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)

Not Applicable

• Conditions: Sleep Apnea Syndromes, Obstructive
• Interventions: Procedure: Minimally invasive, in-office, RF reduction of the affected area

• Registration Number: NCT04367558
• Lead Sponsor: Hillel Yaffe Medical Center

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..

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-27
• Study Start: 2020-06-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	Minimally invasive, in-office, RF reduction of the affected area	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.

Primary Outcome Measures

Name	Time	Method
More than 50% improvement in Apnea-Hypopnea index (AHI)	12 months following the procedure	Measuring the AHI score using sleep laboratory
Reduction of AHI to below 20	12 months following the procedure	Measuring the AHI score using sleep laboratory

Trial Locations

Locations (1)

Hillel Yaffe MC,; 🇮🇱 Hadera, Israel