ACN Stimulation for Obstructive Sleep Apnea
(ACS Trial)
Trial Summary
What is the purpose of this trial?
Recently published data suggest that stimulation of the infrahyoid strap muscles increases pharyngeal patency in patients with obstructive sleep apnea, but the innervation of these muscles by the ansa cervicalis is variable. The investigators propose a study examining the anatomic variation of the ansa cervicalis and the effect of neurostimulation on muscle recruitment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of Ansa Cervicalis Stimulation for treating obstructive sleep apnea?
Research shows that Ansa Cervicalis Stimulation (ACS) can significantly increase the size of the airway and improve airflow in patients with obstructive sleep apnea. When combined with hypoglossal nerve stimulation, ACS further enhances airway stability, suggesting it may be an effective treatment option.12345
Is ACN Stimulation generally safe for humans?
There is no specific safety data available for ACN Stimulation for obstructive sleep apnea, but similar nerve stimulation techniques, like recurrent laryngeal nerve stimulation during surgery, have been described as simple and safe. Additionally, understanding the anatomy of the ansa cervicalis is important to avoid injuries during neck surgeries, suggesting that careful application of such techniques can be safe.678910
How is Ansa Cervicalis Nerve Stimulation different from other treatments for obstructive sleep apnea?
Research Team
David T Kent, M.D.
Principal Investigator
Vanderbilt University Medical Center
Eligibility Criteria
This trial is for adults over 18 who are scheduled for neck surgery due to head and neck cancer. They must be able to give consent, without pre-existing neurological conditions or language barriers that prevent understanding the research, and no history of prior neck surgery that cut the infrahyoid strap muscles.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Procedure
Consented patients undergo neck dissection for cervical lymphadenectomy and dissection of the ansa cervicalis nerves to the infrahyoid strap muscles. Measurements and photos/videos of the common trunks are taken, and an electrode is placed for muscle stimulation.
Follow-up
Participants are monitored for safety and effectiveness after the surgical procedure
Treatment Details
Interventions
- Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor