Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

Recruiting now · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT05501236

Run by

Vanderbilt University Medical Center

People needed

100

Starts

2022-11-03

Expected to finish

2027-11-30

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Consenting adults with BMI≥ 25 and ≤ 40 kg/m2
• 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…

• Chronic use of opiate medications, illicit drug use, or alcohol dependency
• Other known concomitant sleep disorder (e.g., central sleep apnea, periodic limb movements, narcolepsy)
• Clinical history or evidence of cardiopulmonary disease (or oxygen use), liver, renal, immunodeficiency, neurodegenerative diseases, or previous adverse reactions to anesthesia.
• Prior upper airway reconstructive surgery excluding tonsillectomy (e.g., cleft palate repair, uvulopalatopharyngoplasty)
• Indwelling neurostimulation device (e.g. cardiac pacemaker, spinal, vagal, or hypoglossal nerve stimulator)

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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