Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
Polysomnography (PSG) and drug-induced sleep endoscopy (DISE) are widely used diagnostic studies for assessing obstructive sleep apnea (OSA) severity and collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation (HNS) therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. The Investigators propose a study examining the physiologic effect of ansa cervicalis stimulation (ACS) alone and in combination with HNS during PSG and DISE.
Sponsor: Vanderbilt University Medical Center
You may qualify if…
- ✓ 1. Consenting adults with BMI≥ 25 and ≤ 40 kg/m2
- ✓ 2. Obstructive sleep apnea with an AHI between 20 and 80 events/hr (with hypopneas defined by 4% oxyhemoglobin desaturations); ≥80% obstructive events.
You may not qualify if…
- ✕ 1. Chronic use of opiate medications, illicit drug use, or alcohol dependency
- ✕ 2. Other known concomitant sleep disorder (e.g., central sleep apnea, periodic limb movements, narcolepsy)
- ✕ 3. Clinical history or evidence of cardiopulmonary disease (or oxygen use), liver, renal, immunodeficiency, neurodegenerative diseases, or previous adverse reactions to anesthesia.
- ✕ 4. Prior upper airway reconstructive surgery excluding tonsillectomy (e.g., cleft palate repair, uvulopalatopharyngoplasty)
- ✕ 5. Indwelling neurostimulation device (e.g. cardiac pacemaker, spinal, vagal, or hypoglossal nerve stimulator)
Where it's recruiting
Nashville
Source: ClinicalTrials.gov · NCT05501236 · last updated 2025-10-15