Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Sleep Apnea Syndromes, Obstructive

Treatments: Procedure: Minimally invasive, in-office, RF reduction of the affected area

Study type: Interventional

Funder types: Other

Identifiers

NCT04367558

0010-20-HYMC

Details and patient eligibility

About

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..

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Interventional

Experimental group

Description:

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.

Treatment:

Procedure: Minimally invasive, in-office, RF reduction of the affected area