Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)
Primary Purpose
Sleep Apnea Syndromes, Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Minimally invasive, in-office, RF reduction of the affected area
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndromes, Obstructive
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)
Sites / Locations
- Hillel Yaffe MC,Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional
Arm 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.
Outcomes
Primary Outcome Measures
More than 50% improvement in Apnea-Hypopnea index (AHI)
Measuring the AHI score using sleep laboratory
More than 50% improvement in Apnea-Hypopnea index (AHI)
Measuring the AHI score using sleep laboratory
Reduction of AHI to below 20
Measuring the AHI score using sleep laboratory
Reduction of AHI to below 20
Measuring the AHI score using sleep laboratory
Secondary Outcome Measures
Full Information
NCT ID
NCT04367558
First Posted
April 27, 2020
Last Updated
May 26, 2020
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04367558
Brief Title
Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)
Official Title
Possible Efficacy of Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive, in-office, RF reduction of the affected area
Intervention Description
Usage of RF needle to treat one or more of the affected areas
Primary Outcome Measure Information:
Title
More than 50% improvement in Apnea-Hypopnea index (AHI)
Description
Measuring the AHI score using sleep laboratory
Time Frame
6 months following the procedure
Title
More than 50% improvement in Apnea-Hypopnea index (AHI)
Description
Measuring the AHI score using sleep laboratory
Time Frame
12 months following the procedure
Title
Reduction of AHI to below 20
Description
Measuring the AHI score using sleep laboratory
Time Frame
6 months following the procedure
Title
Reduction of AHI to below 20
Description
Measuring the AHI score using sleep laboratory
Time Frame
12 months following the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Itzhak Braverman, MD
Phone
972-4-7744664
Email
braverman@hy.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Isaac Shochat, MD
Phone
972-4-7744664
Email
isaacs@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe MC,
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itzhak Braverman, MD
Phone
972-4-630-4549
Email
braverman@hy.health.gov.il
First Name & Middle Initial & Last Name & Degree
Itzhak Braverman, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)
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