Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)

Sleep Apnea Syndromes, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367558
• Other study ID #: 0010-20-HYMC
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2020
• Source: Hillel Yaffe Medical Center
• Contact: Itzhak Braverman, MD
• Phone: 972-4-7744664
• Email: braverman[@]hy.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea Syndromes, Obstructive
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Minimally invasive, in-office, RF reduction of the affected area
Usage of RF needle to treat one or more of the affected areas

Locations

Country	Name	City	State
Israel	Hillel Yaffe MC,	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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