Stimulation of neck muscles during surgery for head and neck cancer
Intraoperative Identification and Stimulation of the Ansa Cervicalis Nerve Plexus
NA · Vanderbilt University Medical Center · NCT05650710
This study is testing if stimulating neck muscles during surgery for head and neck cancer can help improve breathing in patients with sleep apnea.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05650710 on ClinicalTrials.gov |
What this trial studies
This study investigates the anatomical variation of the ansa cervicalis nerve and its role in stimulating the infrahyoid strap muscles during neck dissection for head and neck cancer. Patients undergoing this procedure will have their ansa cervicalis nerves dissected, and measurements will be taken to assess the nerve's anatomy. An electrode will be applied to stimulate the muscles, with the aim of improving pharyngeal patency in patients with obstructive sleep apnea. The study is designed as a single-arm physiology assessment without a control group.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for neck dissection for cervical lymphadenectomy due to head and neck cancer.
Not a fit: Patients with prior neck surgery affecting the infrahyoid strap muscles or those unable to consent due to neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment options for patients with obstructive sleep apnea by improving muscle function and airway patency.
How similar studies have performed: While there is emerging data on muscle stimulation for obstructive sleep apnea, this specific approach involving the ansa cervicalis nerve is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (≥18 years old). * Scheduled for uni- or bilateral neck dissection (BND) for cervical lymphadenectomy of level IV and other indicated procedures for management of head and neck cancer. Exclusion Criteria: * Unable to consent for research due to a pre-existing neurologic condition as determined by PI. * Unable to consent for research due to language barriers. * History of prior neck surgery with transection of the infrahyoid strap muscles as determined by clinical history.
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.
Conditions: Head and Neck Cancer, Obstructive Sleep Apnea