ACN Stimulation for Obstructive Sleep Apnea

(ACS Trial)

Overseen By Katie Hartley-Estes, RPSGT

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

Trial Summary

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 4 5 11}

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.

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

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

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 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.

Participant Groups

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+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

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]

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 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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Upper Airway Stimulation in OSA]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Ansa cervicalis stimulation increases pharyngeal patency in patients with obstructive sleep apnea. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[The terminal hypoglossal nerve and its anatomical variability]. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Ultrasound Localization and Percutaneous Electrical Stimulation of the Hypoglossal Nerve and Ansa Cervicalis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Transvenous phrenic nerve stimulation to treat idiopathic central sleep apnea. [2021]

6. Poland pubmed.ncbi.nlm.nih.gov

The ansa cervicalis revisited. [2008]

7. England pubmed.ncbi.nlm.nih.gov

Intra-operative recurrent laryngeal nerve stimulation during anterior cervical discectomy: a simple and effective technique. [2011]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Ansa cervicalis: a comprehensive review of its anatomy, variations, pathology, and surgical applications. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

An Unusual Superior Root of the Ansa Cervicalis. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Cervical nerve root stimulation. Part I: technical aspects and normal data. [2008]

11. Germany pubmed.ncbi.nlm.nih.gov

Patient selection for upper airway stimulation: is concentric collapse in sleep endoscopy predictable? [2022]