Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)

Possible Efficacy of Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)

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..

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea Syndromes, Obstructive
• Intervention / Treatment: Procedure: Minimally invasive, in-office, RF reduction of the affected area

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Itzhak Braverman, MD; Phone Number: 972-4-7744664; Email: braverman@hy.health.gov.il
• Study Contact Backup: Name: Isaac Shochat, MD; Phone Number: 972-4-7744664; Email: isaacs@hy.health.gov.il

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Recruiting
    • Hillel Yaffe MC,
    • Contact: Itzhak Braverman, MD; Phone Number: 972-4-630-4549; Email: braverman@hy.health.gov.il
    • Principal Investigator: Itzhak Braverman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Minimally invasive, in-office, RF reduction of the affected area; Usage of RF needle to treat one or more of the affected areas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
More than 50% improvement in Apnea-Hypopnea index (AHI)	Measuring the AHI score using sleep laboratory	6 months following the procedure
More than 50% improvement in Apnea-Hypopnea index (AHI)	Measuring the AHI score using sleep laboratory	12 months following the procedure
Reduction of AHI to below 20	Measuring the AHI score using sleep laboratory	6 months following the procedure
Reduction of AHI to below 20	Measuring the AHI score using sleep laboratory	12 months following the procedure

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 0010-20-HYMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No