Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea
Vanderbilt University Medical Center
Summary
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.
Description
Obstructive Sleep Apnea (OSA) is a common disorder characterized by repetitive upper airway collapse during inspiration caused, in part, by a loss of neuromotor tone in specific upper airway muscles, with multiple associated health sequelae impacting millions of Americans. Patient adherence to the reference treatment, positive airway pressure (PAP), remains problematic. Despite the recent promising development of hypoglossal nerve stimulation (HNS) as a surgical therapy, its indications are limited and a proportion of eligible patients do not achieve sufficient response, leaving a critical unm…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 an…
Interventions
- DeviceGrass 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.
Location
- Vanderbilt University Medical CenterNashville, Tennessee