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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT02364518
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 22 years (no upper limit)
* Regular bed-partner
* Chronic, disruptive snoring according to bed-partner
* Snoring, upper airway resistance syndrome, or mild obstructive sleep apnea (AHI ≤ 15; lowest O2 saturation ≥ 85%) on home sleep testing with Watch-PAT
* No prior surgical treatment for snoring or OSAS other than nasal surgery
* Willing and capable of providing informed consent
Exclusion Criteria:
* Age \< 22 years
* No regular bed-partner
* Intermittent or occasional snoring
* Moderate-to-severe obstructive sleep apnea (AHI ≥ 16; Lowest O2 sat \<85%) or evidence of central apnea (≥ 10% of apneic events) on home sleep testing with Watch-PAT
* BMI ≥ 32 kg/m2
* Modified Mallampati 3 or 4
* Tonsil Grade 3 or 4
* Significant nasal obstruction (\> 50% of nasal airway diameter on one side)
* Previous palatal surgery (cleft palate; uvulopalatopharyngoplasty; uvulectomy; Pillar implants; Somnoplasty)
* Current cigarette smoker (≥ 1 cigarette per day)
* Known history of coronary artery disease or stroke
* Chronic obstructive pulmonary disease (COPD)
* Diabetes
* Major depression or non-controlled psychiatric illness
* Drug or alcohol abuse
* Untreated or poorly controlled hypertension
* Anticoagulation therapy (ex. Coumadin or Plavix; single baby aspirin per day allowable)
* History of bleeding or clotting disorder
* 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
* 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 and/or be using an acceptable form of birth control (OCPs; IUD).
* Major depression or non-stabilized psychiatric disorder
* Drug or alcohol abuse
* Previous palatal or tongue surgery
* Stable or unstable angina
* CHF
* Moderate or severe valvular disease
* TIA/CVA
* Carotid stenosis or endarterectomy
* Anemia
* Room air 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:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT02364518
Study Brief:
Protocol Section:
NCT02364518