Nerve Stimulation for Obstructive Sleep Apnea

Overseen By Kate Von Wahlde

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Neurologic condition, Other sleep disorder, Previous pharyngeal surgery, Chemoradiation therapy, Indwelling neurostimulation device

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether stimulating a specific nerve in the throat can help keep the airway open during sleep for people with obstructive sleep apnea (OSA). Researchers will use a nerve stimulation device and a sterile wire electrode to deliver small electrical signals, aiming to improve breathing by engaging certain throat muscles. It targets adults with moderate-to-severe OSA who are scheduled for surgery to remove a mass in their throat area and do not have other sleep or nerve issues. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future treatments for OSA.

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 nerve stimulation device is safe for obstructive sleep apnea?

Research shows that nerve stimulation can safely treat sleep apnea. Studies have found it effective for patients unable to use traditional treatments like CPAP machines. One study found that this stimulation significantly improved sleep apnea symptoms by reducing breathing interruptions.

Another study confirmed the effectiveness and safety of these devices, showing they successfully lower the apnea-hypopnea index, which measures sleep apnea severity. Overall, evidence suggests that nerve stimulation is safe and generally well-accepted by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Nerve stimulation for obstructive sleep apnea is unique because it targets the condition by using a nerve stimulation device and a sterile wire electrode to activate specific nerves. Unlike traditional treatments like CPAP machines or oral appliances that focus on managing airflow, this approach directly stimulates the nerves involved in breathing regulation. Researchers are excited about this treatment as it offers a non-invasive alternative that could improve comfort and compliance for patients, potentially leading to better long-term outcomes.

What evidence suggests that nerve stimulation is effective for obstructive sleep apnea?

Research shows that stimulating certain nerves can help treat obstructive sleep apnea. For example, studies have found that stimulating the hypoglossal nerve, which controls tongue movement, can greatly reduce sleep apnea symptoms. One study reported a decrease in breathing interruptions during sleep by about 21 times per hour. Patients also felt less sleepy during the day and experienced a better overall quality of life. In this trial, participants will undergo a surgical procedure to receive nerve stimulation using a nerve stimulation device and sterile wire electrode. These findings suggest that nerve stimulation to keep the airway open can be effective for people with obstructive sleep apnea. ^{2 4 6 7 8}

Who Is on the Research Team?

David T. Kent

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for consenting adults with a BMI between 25 and 40 who have moderate-to-severe Obstructive Sleep Apnea or are at high risk based on STOP-BANG criteria. Participants must be planning to undergo surgery for a parapharyngeal space mass without nerve function issues.

Inclusion Criteria

My BMI is between 25 and 40.

I have been diagnosed with severe sleep apnea or am at high risk based on a test.

I am scheduled for surgery to remove a neck mass and have no issues with nerve function.

Exclusion Criteria

You have a medical device implanted in your body to help with nerve stimulation, like a pacemaker or nerve stimulator.

Unable to consent for research due to a pre-existing neurologic condition or language barriers as determined by PI

I have had chemoradiation therapy for head or neck cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Consented patients undergo parapharyngeal space surgery for tumor extirpation, with dissection and exposure of the glossopharyngeal nerve branches. Measurements and photos/videos of the nerve are taken, and fine-wire electrodes are placed for stimulation.

Single operative procedure

1 visit (in-person)

Drug-Induced Sleep Endoscopy (DISE)

Following surgery, patients undergo DISE to assess muscle activation and changes in upper airway patency using various measurements.

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nerve stimulation using nerve stimulation device and sterile wire electrode

Trial Overview The study tests how stimulating the glossopharyngeal nerve affects muscle control and airway openness during surgery in patients with sleep apnea. It involves using a special device and electrode to apply electrical stimulation.

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

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]

The Genio™ system for bilateral hypoglossal nerve stimulation (HNS) significantly reduced the severity of obstructive sleep apnea (OSA) after 6 months, with the apnoea-hypopnoea index (AHI) decreasing from 23.7 to 12.9 events per hour (p<0.001).

Participants also reported improvements in daytime sleepiness and sleep-related quality of life, with no serious device-related adverse events occurring during the study, indicating a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eastwood, PR., Barnes, M., MacKay, SG., et al.[2021]

Hypoglossal nerve stimulation (HNS) has shown promising results in treating moderate-to-severe obstructive sleep apnea (OSA), with follow-up studies indicating similar or improved apnea-hypopnea index (AHI) outcomes since the Inspire device's FDA approval in 2014.

The use of drug-induced sedation endoscopy (DISE) has emerged as a valuable tool for assessing patient eligibility for HNS, highlighting the importance of a coordinated approach between medical and surgical management for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights since FDA Approval of Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea. Strohl, MM., Yamauchi, M., Peng, Z., et al.[2022]

In a study of 76 patients with obstructive sleep apnea, hypoglossal nerve stimulation significantly improved sleep metrics, reducing the median apnea-hypopnea index from 30.0 to 18.6 events per hour and the Epworth Sleepiness Scale from 13.5 to 7.6 after 12 months.

Modifying stimulation parameters from 90 μsec at 33 Hz to 120 μsec at 40 Hz reduced the voltage needed for effective tongue protrusion, indicating a potential for optimizing treatment while maintaining efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impulse Configuration in Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea: The Effect of Modifying Pulse Width and Frequency. Steffen, A., Jeschke, S., Soose, RJ., et al.[2022]

In a study involving 60 patients with obstructive sleep apnea, selective upper airway stimulation significantly reduced the apnea-hypopnea index from an average of 28.6 events per hour to 8.3 events per hour after 6 months, indicating strong efficacy in improving sleep quality.

All patients reported improvements in sleep and daytime symptoms, and there were no surgical revisions required for the implanted system, highlighting the safety of this new surgical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. Heiser, C., Maurer, JT., Hofauer, B., et al.[2022]

Upper airway stimulation (UAS) significantly reduced the apnea-hypopnea index (AHI) from 37.4 to 8.7 events per hour after 12 months, indicating its effectiveness in treating moderate-to-severe obstructive sleep apnea.

The treatment had a high surgical success rate of 96%, although 28% of patients reported adverse events, suggesting that while UAS is generally safe, some patients may experience complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Airway Stimulation in Patients with Obstructive Sleep Apnea: Long-Term Surgical Success, Respiratory Outcomes, and Patient Experience. Veugen, CCAFM., Dieleman, E., Hardeman, JA., et al.[2023]

Hypoglossal nerve stimulation is an effective treatment for obstructive sleep apnea (OSA), achieving over an 80% success rate in improving symptoms.

Patients using this device report high tolerance and adherence to therapy, with many preferring it over traditional continuous positive airway pressure (CPAP) therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal Nerve (Cranial Nerve XII) Stimulation. Yu, JL., Thaler, ER.[2020]

Hypoglossal nerve stimulation (HGNS) significantly improves apnea-hypopnea indices (AHI) in patients with obstructive sleep apnea (OSA) who are intolerant to CPAP, with median AHI decreasing from 38.5 to 2.7 after treatment.

Patient characteristics such as a higher Friedman tongue position (grade IV) and Mallampati score (III/IV) were linked to a lesser response to HGNS, indicating that these measures can help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Predictors of Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. Xiao, R., Trask, DK., Kominsky, AH.[2020]

The Upper Airway Stimulation (UAS) system is shown to be a safe and effective treatment for moderate to severe obstructive sleep apnea (OSA) in patients who are unable or unwilling to use CPAP, with significant improvements in apnea hypopnea index (AHI) and sleep quality measures after 6 months.

Successful therapy response was associated with specific baseline characteristics, including a body mass index (BMI) of 32 or less and an AHI of 50 or less, indicating that patient selection can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implanted upper airway stimulation device for obstructive sleep apnea. Van de Heyning, PH., Badr, MS., Baskin, JZ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12401310/

Comparative efficacy of electrical stimulation therapies for ... The objective of this study was to compare the efficacy of hypoglossal nerve stimulation (HNS), submental electrical stimulation (SMES), and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0954611124003019

Hypoglossal nerve stimulation for obstructive sleep apnea ... The Apnex device resulted in short-term reductions in AHI (-21.66 events/h), ODI (-6.38 events/h), and ESS (-4.13), with a 2.59 improvement in FOSQ score. •.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690581/

Hypoglossal Nerve Stimulation and Cardiovascular ... This randomized clinical trial assesses the effect of hypoglossal nerve stimulation vs sham intervention on blood pressure, sympathetic activity, and vascular ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1308659

Upper-Airway Stimulation for Obstructive Sleep Apnea We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea.

5. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2803487

Targeted Hypoglossal Nerve Stimulation for Patients With ... The results of this randomized clinical trial found that proximal targeted hypoglossal nerve responses proved safe and effective in treating sleep apnea.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6364516/

The outcomes of hypoglossal nerve stimulation in ... HNS is a safe and effective treatment for CPAP refractory OSA. HNS is associated with high compliance and significantly improves subjective and objective ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06283030

Evaluation of Hypoglossal Nerve Stimulation in Humans ... Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea ... Characterization of electrode array outcomes, Spatial ...

8. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2812536

Hypoglossal Nerve Stimulation and Cardiovascular ... This randomized clinical trial assesses the effect of hypoglossal nerve stimulation vs sham intervention on blood pressure, ...