Stimulation of nerves to treat obstructive sleep apnea
Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea
This study is testing if stimulating certain nerves can help people with obstructive sleep apnea breathe better during sleep, especially for those who haven't found relief with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05501236 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates include adults with a BMI between 25 and 40 kg/m2 and an apnea-hypopnea index (AHI) of 20 to 80 events per hour.
Not a fit: Patients with chronic use of opiate medications, other sleep disorders, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment option for patients with obstructive sleep apnea who struggle with current therapies.
How similar studies have performed: While hypoglossal nerve stimulation has shown promise, the specific combination of ACS and HNS is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.