Stimulation of nerves to treat obstructive sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of ansa cervicalis stimulation (ACS) alone and in combination with hypoglossal nerve stimulation (HNS) on patients with obstructive sleep apnea (OSA). It aims to explore how these stimulation techniques can improve airway patency during sleep by targeting specific muscles involved in maintaining upper airway structure. The study will utilize polysomnography (PSG) and drug-induced sleep endoscopy (DISE) to assess the physiological responses and effectiveness of the interventions. The goal is to provide a new therapeutic option for patients who do not respond adequately to existing treatments like positive airway pressure (PAP).

Why it matters

Who can join: the full rules

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)

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: David T. Kent, MD — Vanderbilt University Medical Center
• Study coordinator: Katie Hartley-Estes, RPSGT
• Email: katherine.e.hartley@vumc.org
• Phone: 615-875-9214

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• CES-EES score and a wearable ring for diagnosing obstructive sleep apnea

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.