RECRUITINGINTERVENTIONAL

Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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, weakened immune system, 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 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. Exclusion Criteria: 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)

Treatments Being Tested

DEVICE

Grass S88 Muscle Stimulator

The Grass S88 nerve and muscle stimulator is a widely-used tool in electromyography and nerve conduction studies. During the DISE and second sleep study, fine-wire electrodes will be placed into the hypoglossal nerve or genioglossus muscle. Two more electrodes are placed transcutaneously, proximate to the bilateral branches of the cervicalis innervating the sternothyroid muscle in the anterior neck.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States