Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT02349893
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT02349893
Study Brief:
Protocol Section:
NCT02349893