NCT05501236 Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA
| NCT ID | NCT05501236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-11-03 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-11-03 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
David T. Kent, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT05501236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05501236 currently recruiting?
Yes, NCT05501236 is actively recruiting participants. Contact the research team at katherine.e.hartley@vumc.org for enrollment information.
Where is the NCT05501236 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05501236 clinical trial?
NCT05501236 is sponsored by Vanderbilt University Medical Center. The principal investigator is David T. Kent, MD at Vanderbilt University Medical Center. The trial plans to enroll 100 participants.