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Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study

Primary Purpose

Apnea, Sleep

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RFA treatment

About this trial

This is an interventional treatment trial for Apnea, Sleep

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults (≥ 22 years)
Self-report of daytime somnolence
Body mass index (BMI) ≤ 32
Mild to moderate obstructive sleep apnea (AHI 10 - 30; lowest O2 sat ≥ 80%)
Evidence of palate and tongue base collapse on supine fiberoptic examination
Non-compliant with or refusal of continuous positive airway pressure therapy (CPAP) (< 4 hours per night by patient report)
No prior surgical treatment for OSAS other than nasal surgery
Willing and capable of providing informed consent

Exclusion Criteria:

Another significant sleep disorder (e.g., insomnia, periodic limb movement)
Tonsillar hypertrophy
Chronic Obstructive Pulmonary Disease (COPD)
Interstitial Lung Disease (ILD)
Cystic Fibrosis
Acute Repiratory Distress Syndrome (ARDS)
Nasal or supraglottic obstruction on fiberoptic examination
American Society of Anesthesiologists (ASA) class III ,IV, V
Latex allergy
Lidocaine allergy
Pregnancy or plans to become pregnant Note: women of childbearing potential must demonstrate a negative pregnancy test upon enrollment; those patients qualified to progress to RFA must also demonstrate a negative pregnancy test within 7 days prior to the date of RFA procedure.
Major depression or non-stabilized psychiatric disorder
Drug or alcohol abuse
Previous palatal or tongue surgery
Stable or unstable angina
congestive heart failure (CHF)
moderate or severe valvular disease
transient ischemic attack (TIA)/cardiovascular accident (CVA)
Carotid stenosis or endarterectomy
Anemia
Room air oxygen saturation (SpO2) < 95%
Pulmonary hypertension
Dialysis
Central or mixed apnea ≥ 10% of respiratory events
Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study

Sites / Locations

Alessi Clinic
Otolaryngology Colorado
ENT of Georgia
Bluesleep clinic
Institutional Review Board for Human Research (IRB)
Methodist Healthcare Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RFA treatment

Arm Description

RFA treatment performed with CelonProSleep plus device

Outcomes

Primary Outcome Measures

Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline

The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.

Secondary Outcome Measures

Full Information

NCT ID

NCT02349893

First Posted

January 24, 2015

Last Updated

June 27, 2022

Sponsor

Olympus Surgical Technologies Europe

1. Study Identification

Unique Protocol Identification Number

NCT02349893

Brief Title

Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study

Official Title

Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Olympus Surgical Technologies Europe

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents. This study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apnea, Sleep

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RFA treatment

Arm Type

Experimental

Arm Description

RFA treatment performed with CelonProSleep plus device

Intervention Type

Device

Intervention Name(s)

RFA treatment

Intervention Description

RFA treatment using CelonProSleep plus system

Primary Outcome Measure Information:

Title

Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline

Description

The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.

Time Frame

6 months following last treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults (≥ 22 years) Self-report of daytime somnolence Body mass index (BMI) ≤ 32 Mild to moderate obstructive sleep apnea (AHI 10 - 30; lowest O2 sat ≥ 80%) Evidence of palate and tongue base collapse on supine fiberoptic examination Non-compliant with or refusal of continuous positive airway pressure therapy (CPAP) (< 4 hours per night by patient report) No prior surgical treatment for OSAS other than nasal surgery Willing and capable of providing informed consent Exclusion Criteria: Another significant sleep disorder (e.g., insomnia, periodic limb movement) Tonsillar hypertrophy Chronic Obstructive Pulmonary Disease (COPD) Interstitial Lung Disease (ILD) Cystic Fibrosis Acute Repiratory Distress Syndrome (ARDS) Nasal or supraglottic obstruction on fiberoptic examination American Society of Anesthesiologists (ASA) class III ,IV, V Latex allergy Lidocaine allergy Pregnancy or plans to become pregnant Note: women of childbearing potential must demonstrate a negative pregnancy test upon enrollment; those patients qualified to progress to RFA must also demonstrate a negative pregnancy test within 7 days prior to the date of RFA procedure. Major depression or non-stabilized psychiatric disorder Drug or alcohol abuse Previous palatal or tongue surgery Stable or unstable angina congestive heart failure (CHF) moderate or severe valvular disease transient ischemic attack (TIA)/cardiovascular accident (CVA) Carotid stenosis or endarterectomy Anemia Room air oxygen saturation (SpO2) < 95% Pulmonary hypertension Dialysis Central or mixed apnea ≥ 10% of respiratory events Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaun Nguyen, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alessi Clinic

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90212

Country

United States

Facility Name

Otolaryngology Colorado

City

Greenwood Village

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

Facility Name

ENT of Georgia

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Bluesleep clinic

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Name

Institutional Review Board for Human Research (IRB)

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425-8570

Country

United States

Facility Name

Methodist Healthcare Foundation

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38104

Country

United States

12. IPD Sharing Statement

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Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study

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