50 Participants Needed

ACN Stimulation for Obstructive Sleep Apnea

(ACS Trial)

KV
MS
KH
Overseen ByKatie Hartley-Estes, RPSGT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Ansa Cervicalis Nerve Stimulation (ACS) is unique because it targets the sternothyroid muscle to stabilize the pharynx, potentially enhancing the effectiveness of existing hypoglossal nerve stimulation (HNS) by reducing pharyngeal collapsibility and increasing airflow during sleep.124511

Research Team

DT

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

I am scheduled for surgery to remove lymph nodes in my neck due to head and neck cancer.
I am 18 years old or older.

Exclusion Criteria

I had neck surgery that involved cutting muscles below my voice box.
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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

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.

Single operative procedure
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

4 weeks

Treatment Details

Interventions

  • Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation
Trial OverviewThe study tests nerve stimulation on a nerve called ansa cervicalis during surgery. It aims to see if stimulating this nerve can help open up the airway in patients with obstructive sleep apnea by activating certain neck muscles.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Surgical ProcedureExperimental Treatment1 Intervention
Consented patients who meet eligibility will have a surgical procedure for management of head and neck cancer, with dissection and exposure of the relevant anatomic structures as part of regular clinical care.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Findings from Research

Hypoglossal nerve stimulation (HNS) is an effective new treatment for moderate to severe obstructive sleep apnea (OSA) in patients who cannot tolerate continuous positive airway pressure (CPAP), as shown in the multicenter STAR study.
The Inspire™ system for HNS significantly improves both objective and subjective measures of OSA severity by preventing pharyngeal collapse during sleep without waking the patient.
[Upper Airway Stimulation in OSA].Bender, B.[2018]
In a study involving 8 participants with obstructive sleep apnea (OSA), stimulation of the ansa cervicalis (ACS) significantly increased the retropalatal cross-sectional area during expiration, suggesting it helps stabilize the airway.
Combining ACS with hypoglossal nerve stimulation (HNS) resulted in a 180% greater increase in airway size and a 254% increase in expiratory airflow compared to HNS alone, indicating that ACS may enhance the effectiveness of HNS in reducing pharyngeal collapsibility.
Ansa cervicalis stimulation increases pharyngeal patency in patients with obstructive sleep apnea.Kent, DT., Scott, WC., Zealear, D., et al.[2023]
Upper airway stimulation targeting the hypoglossal nerve (N. XII) is an effective treatment for obstructive sleep apnea (OSA) by helping to open the airway through tongue protrusion.
Successful implantation of stimulation systems relies on understanding the anatomical variations of the N. XII and using intraoperative neuromonitoring to ensure accurate electrode placement for optimal tongue movement.
[The terminal hypoglossal nerve and its anatomical variability].Heiser, C., Knopf, A., Hofauer, B.[2020]

References

[Upper Airway Stimulation in OSA]. [2018]
Ansa cervicalis stimulation increases pharyngeal patency in patients with obstructive sleep apnea. [2023]
[The terminal hypoglossal nerve and its anatomical variability]. [2020]
Ultrasound Localization and Percutaneous Electrical Stimulation of the Hypoglossal Nerve and Ansa Cervicalis. [2022]
Transvenous phrenic nerve stimulation to treat idiopathic central sleep apnea. [2021]
The ansa cervicalis revisited. [2008]
Intra-operative recurrent laryngeal nerve stimulation during anterior cervical discectomy: a simple and effective technique. [2011]
Ansa cervicalis: a comprehensive review of its anatomy, variations, pathology, and surgical applications. [2020]
An Unusual Superior Root of the Ansa Cervicalis. [2020]
Cervical nerve root stimulation. Part I: technical aspects and normal data. [2008]
Patient selection for upper airway stimulation: is concentric collapse in sleep endoscopy predictable? [2022]