Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)

NCT ID: NCT04367558

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-05-31

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..

Conditions

Sleep Apnea Syndromes, Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Usage of RF needle to treat one or more of the affected areas

Interventions

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

Usage of RF needle to treat one or more of the affected areas

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hillel Yaffe MC,

Hadera, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Itzhak Braverman, MD

Role: CONTACT

braverman@hy.health.gov.il

972-4-7744664

Isaac Shochat, MD

Role: CONTACT

isaacs@hy.health.gov.il

972-4-7744664

Facility Contacts

Itzhak Braverman, MD

Role: primary

braverman@hy.health.gov.il

972-4-630-4549

Other Identifiers

0010-20-HYMC

Identifier Type: -

Identifier Source: org_study_id