ACN Stimulation for Obstructive Sleep Apnea

(ACS Trial)

Overseen By Nicole L Jones, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Neurologic condition, Language barriers, Prior neck surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with obstructive sleep apnea, a condition where breathing stops and starts during sleep. Researchers are testing whether stimulating specific neck muscles using Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation can keep the airways open. The study involves patients already scheduled for neck surgery due to head and neck cancer. It suits those who will undergo neck surgery and have not had previous neck surgery affecting certain muscles. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future treatments for obstructive sleep apnea.

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 prior data suggests that this stimulation technique is safe for patients with obstructive sleep apnea?

Research has shown that specific safety information for ACN Stimulation, a treatment for obstructive sleep apnea, is limited. However, similar nerve stimulation methods, such as those used on the recurrent laryngeal nerve, have been applied in other medical treatments. These methods are generally well-tolerated, with few serious side effects reported.

The current trial is in a phase labeled "Not Applicable," indicating that researchers are still assessing the treatment's safety for people. While some understanding of its effects exists, further research is necessary to fully confirm its safety. Participants should consider this when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation for obstructive sleep apnea because it offers a novel approach by directly targeting nerve pathways involved in airway control. Unlike standard treatments like CPAP machines, which rely on external pressure to keep airways open, ACN stimulation aims to enhance natural muscle function through nerve stimulation. This method could potentially offer a more lasting solution by improving the body's own ability to maintain an open airway during sleep.

What evidence suggests that ACN Stimulation is effective for obstructive sleep apnea?

Research shows that Ansa Cervicalis Stimulation (ACS), which participants in this trial will receive, can significantly widen the airway and improve breathing in people with obstructive sleep apnea. Previous studies have demonstrated that stimulating certain neck muscles, which help open the throat, can make breathing easier during sleep. Ansa cervicalis stimulation has improved airflow more effectively than other methods, such as hypoglossal nerve stimulation, during the same breath. This suggests that ACS could be a promising option for people dealing with obstructive sleep apnea. ^{1 2 3 4 6}

Who Is on the Research Team?

David T Kent, M.D.

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation

Trial Overview The 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.

How Is the Trial Designed?

Group I: Surgical Procedure Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

A study of 100 adult cadavers revealed significant anatomical variations in the ansa cervicalis (AC), which is crucial for avoiding nerve injuries during esophageal cancer surgery.

Understanding the specific origins and pathways of the AC can help surgeons prevent complications related to recurrent laryngeal nerve paralysis, enhancing the safety and efficacy of nerve-muscle transplantation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ansa cervicalis revisited. Loukas, M., Thorsell, A., Tubbs, RS., et al.[2008]

Transvenous phrenic nerve stimulation significantly improved sleep metrics in patients with idiopathic central sleep apnea (ICSA) over an 18-month period, with reductions in the apnea-hypopnea index (AHI) and central apnea index by approximately 25 events per hour at each follow-up (P < .001).

Patients reported meaningful improvements in quality of life, including reduced daytime sleepiness and fatigue, with only one serious adverse event (lead component failure) noted, indicating a favorable safety profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvenous phrenic nerve stimulation to treat idiopathic central sleep apnea. Javaheri, S., McKane, S.[2021]

In a study of 74 patients with obstructive sleep apnea, about 20% exhibited concentric palatal collapse during sleep endoscopy, which is a critical factor for determining eligibility for upper airway stimulation therapy.

Higher body mass index (BMI) and apnea hypopnea index values were predictive of concentric collapse, but many severely overweight patients did not show this condition, indicating that other factors beyond weight may influence airway structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient selection for upper airway stimulation: is concentric collapse in sleep endoscopy predictable? Steffen, A., Frenzel, H., Wollenberg, B., et al.[2022]

The ansa cervicalis, a neural loop that innervates the infrahyoid muscles, typically has a superior root that shows uncommon anatomical variations.

This study reports an extremely rare case where the superior root of the ansa cervicalis originates from both the hypoglossal and vagus nerves, highlighting a unique anatomical variation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Unusual Superior Root of the Ansa Cervicalis. Kikuta, S., Iwanaga, J., Kusukawa, J., et al.[2020]

Cervical nerve root stimulation (CRS) provides normative data on CMAP onset-latencies and changes in amplitude, area, and duration for muscles like the abductor pollicis brevis and biceps, which can help assess nerve function in clinical settings.

The study found that CRS is well-tolerated by healthy individuals, with a mean discomfort score of 3.8 on a visual analog scale, indicating it is a safe technique for evaluating nerve conduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical nerve root stimulation. Part I: technical aspects and normal data. Vucic, S., Cairns, KD., Black, KR., et al.[2008]

Intra-operative neuromonitoring using recurrent laryngeal nerve (RLN) stimulation during anterior cervical discectomy (ACD) surgery was evaluated in 19 patients, showing promise in reducing the risk of RLN palsy, a common complication of the procedure.

The technique is described as simple and safe, suggesting it could be a beneficial practice to enhance patient safety during ACD surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-operative recurrent laryngeal nerve stimulation during anterior cervical discectomy: a simple and effective technique. Tisdall, MM., Henn, C., Dorward, NL.[2011]

The ansa cervicalis is a crucial neural loop in the neck formed by connections from cervical spinal nerves C1-2 and C2-3, which can vary anatomically.

Understanding the anatomy and variations of the ansa cervicalis is important for surgical procedures in the neck region to avoid complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ansa cervicalis: a comprehensive review of its anatomy, variations, pathology, and surgical applications. Kikuta, S., Jenkins, S., Kusukawa, J., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The terminal hypoglossal nerve and its anatomical variability]. Heiser, C., Knopf, A., Hofauer, B.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ansa cervicalis stimulation increases pharyngeal patency in patients with obstructive sleep apnea. Kent, DT., Scott, WC., Zealear, D., et al.[2023]

In a study involving 15 participants with obstructive sleep apnea (OSA), both the hypoglossal nerve and the ansa cervicalis were successfully localized and stimulated using percutaneous electrodes, demonstrating a high success rate of 100% for localization and 86.7% for hypoglossal nerve stimulation.

No complications were reported during the procedure, indicating that this method of nerve stimulation is safe, and further research with larger trials could help refine patient selection for respiratory neurostimulation therapies in OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound Localization and Percutaneous Electrical Stimulation of the Hypoglossal Nerve and Ansa Cervicalis. Kent, DT., Schwartz, AR., Zealear, D.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Upper Airway Stimulation in OSA]. Bender, B.[2018]

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/388577

Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation Recently published data suggest that stimulation of the infrahyoid strap muscles increases pharyngeal patency in patients with obstructive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8097630/

Ansa Cervicalis Stimulation: A New Direction in ... B, Ansa cervicalis stimulation had a significant effect on VImax compared with hypoglossal nerve stimulation within the same breath in a generalized linear ...

3. withpower.com withpower.com/trial/acn-stimulation-for-obstructive-sleep-apnea-d3d23

ACN Stimulation for Obstructive Sleep Apnea (ACS Trial) Research shows that Ansa Cervicalis Stimulation (ACS) can significantly increase the size of the airway and improve airflow in patients with obstructive sleep ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05650710?term=David+Jones

Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation Recently published data suggest that stimulation of the infrahyoid strap muscles increases pharyngeal patency in patients with obstructive sleep apnea, but the ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05650710/intraoperative-ansa-cervicalis-nerve-acn-stimulation

Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation Recently published data suggest that stimulation of the infrahyoid strap muscles increases pharyngeal patency in patients with obstructive ...

6. foundation.aasm.org foundation.aasm.org/ansa-cervicalis-neurostimulation-in-obstructive-sleep-apnea/

Ansa Cervicalis Neurostimulation in Obstructive Sleep Apnea This project was designed to evaluate the effect of ansa cervicalis stimulation (ACS) of the sternothyroid muscle on upper airway patency in patients with ...