Clinical trial NCT02349893: 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
Overall status: COMPLETED
Phase: NA
Conditions: Apnea, Sleep
Lead sponsor: Olympus Surgical Technologies Europe
Sponsor class: INDUSTRY
First posted: 2015-01-29
Enrollment: 56
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline
timeFrame: 6 months following last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Alessi Clinic
state: California
city: Greenwood Village
country: United States
facility: Otolaryngology Colorado
state: Colorado
city: Atlanta
country: United States
facility: ENT of Georgia
state: Georgia
city: New York
country: United States
facility: Bluesleep clinic
state: New York
city: Charleston
country: United States
facility: Institutional Review Board for Human Research (IRB)
state: South Carolina
city: Memphis
country: United States
facility: Methodist Healthcare Foundation
state: Tennessee
Study officials:
affiliation: Medical University of South Carolina
name: Shaun Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: