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

Study Overview
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Brief Summary
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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).

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

Conditions
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Apnea, Sleep

Intervention / Treatment
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* Device: RFA treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA treatment<br>RFA treatment performed with CelonProSleep plus device | Device: RFA treatment<br>* RFA treatment using CelonProSleep plus system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline | The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline. | 6 months following last treatment |