Nerve Stimulation for Obstructive Sleep Apnea

Overseen By Nicole L Jones, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Opiates, Illicit drugs, Alcohol

Disqualifiers: Cardiopulmonary disease, Neurodegenerative diseases, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for obstructive sleep apnea using a device that stimulates muscles to keep airways open during sleep. Researchers aim to evaluate the effectiveness of stimulating a specific neck nerve both alone and in combination with an existing treatment. The trial uses the Grass S88 muscle stimulator during sleep studies to determine the best approach. Ideal participants are adults diagnosed with obstructive sleep apnea, experiencing at least 20 sleep interruptions per hour, and having a BMI between 25 and 40. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using opiate medications regularly, you would not be eligible to participate.

What prior data suggests that this nerve stimulation technique is safe for treating obstructive sleep apnea?

Research shows that hypoglossal nerve stimulation (HNS) and similar treatments are generally well-tolerated by people with obstructive sleep apnea. Studies have demonstrated that this type of nerve stimulation can greatly reduce the severity of apnea without causing serious side effects.

For example, one study found that after a year of treatment, the severity of sleep apnea decreased significantly, with the apnea-hypopnea index (AHI) dropping from 28.6 to 9.5, indicating a substantial improvement in breathing during sleep. Another study noted that improvements in sleepiness and quality of life lasted up to five years with hypoglossal nerve stimulation, and serious side effects were rare.

These findings suggest that using the Grass S88 muscle stimulator for nerve stimulation is likely safe. However, like any treatment, some side effects might occur, but they are usually not severe. Prospective trial participants may find these results reassuring regarding the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for obstructive sleep apnea, like CPAP machines and oral appliances, focus on keeping airways open mechanically. But the Grass S88 Muscle Stimulator takes a different approach by using nerve stimulation to target the muscles involved in breathing. This innovative method aims to enhance muscle function and keep airways open naturally during sleep. Researchers are excited about this treatment because it offers a potentially less invasive and more comfortable solution for sleep apnea sufferers, which could lead to better patient compliance and improved sleep quality.

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

Research has shown that stimulating the hypoglossal nerve can significantly aid people with obstructive sleep apnea (OSA). One study found that the apnea-hypopnea index (AHI), which measures breathing interruptions during sleep, decreased from 28.6 to 9.5 after 12 months of treatment. This reduction indicates fewer breathing problems during sleep. Participants also reported improved sleep quality and overall life satisfaction over five years. Serious side effects were rare, suggesting it as a promising option for treating OSA. This trial tests the Grass S88 Muscle Stimulator to harness these benefits by targeting the nerves that help keep the airway open during sleep. ^{1 3 4 6 7}

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 consenting adults with a BMI between 25 and 40, diagnosed with moderate to severe obstructive sleep apnea (OSA), characterized by an AHI of 20-80 events/hr. It's not suitable for those with neurostimulation devices, chronic opiate use, alcohol dependency, other sleep disorders, significant cardiopulmonary disease or history of upper airway surgery.

Inclusion Criteria

My BMI is between 25 and 40.

I have sleep apnea with 20-80 breathing pauses per hour, mostly obstructive.

Exclusion Criteria

I have had surgery on my upper airway, but not for removing my tonsils.

I have a history of heart, lung, liver, kidney diseases, immune issues, brain disorders, or bad reactions to anesthesia.

You have a device implanted in your body to stimulate your nerves, like a pacemaker or spinal stimulator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo drug-induced sleep endoscopy (DISE) and polysomnography (PSG) with ansa cervicalis stimulation (ACS) and hypoglossal nerve stimulation (HNS)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Grass S88 Muscle Stimulator

Trial Overview The study tests the effects of ansa cervicalis stimulation (ACS) alone and combined with hypoglossal nerve stimulation (HNS) on OSA. Participants will undergo polysomnography and drug-induced sleep endoscopy to assess the impact on their upper airway during sleep.

How Is the Trial Designed?

Group I: Muscle stimulation Experimental Treatment 1 Intervention

Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and second sleep study and the Grass S88 (or comparable) muscle stimulator.

Grass S88 Muscle Stimulator is already approved in United States, European Union for the following indications:

Approved in United States as Inspire Upper Airway Stimulation for:

• Moderate to severe obstructive sleep apnea (OSA)

Approved in European Union as Hypoglossal Nerve Stimulation for:

• Moderate to severe obstructive sleep apnea (OSA)

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

In a study of 14 patients with moderate-to-severe obstructive sleep apnea who were intolerant to CPAP, the use of an implantable hypoglossal nerve stimulation (HNS) device alongside existing cardiac implantable electronic devices (CIEDs) was found to be safe and effective over a 1-year follow-up period.

No device-device interactions were observed, as intraoperative testing confirmed that HNS stimulation did not affect the sensing capabilities of the CIEDs, indicating that these two devices can be used together without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early feasibility of hypoglossal nerve upper airway stimulator in patients with cardiac implantable electronic devices and continuous positive airway pressure-intolerant severe obstructive sleep apnea. Parikh, V., Thaler, E., Kato, M., et al.[2019]

Hypoglossal nerve stimulation (HNS) therapy significantly reduced the apnea-hypopnea index (AHI) in patients with moderate to severe obstructive sleep apnea (OSA), achieving normalization (AHI < 5) in 65% of patients, compared to traditional uvulopalatopharyngoplasty (UPPP) which only reduced AHI to an average of 28.8.

Both HNS and UPPP are effective for OSA patients intolerant to CPAP, but HNS shows superior outcomes, indicating it may be a more 'curative' option for select patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uvulopalatopharyngoplasty vs CN XII stimulation for treatment of obstructive sleep apnea: A single institution experience. Shah, J., Russell, JO., Waters, T., et al.[2018]

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]

Hypoglossal nerve stimulation (HNS) with Inspire is a cost-effective treatment for patients with moderate to severe obstructive sleep apnoea who cannot tolerate CPAP, showing an incremental cost-effectiveness ratio of £17,989 per quality-adjusted life-year (QALY) gained.

Patients receiving HNS are expected to gain more quality-adjusted life years (12.72 QALYs) compared to those receiving no treatment (11.15 QALYs), indicating that HNS not only improves health outcomes but is also a financially viable option for the NHS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breathing Synchronised Hypoglossal Nerve Stimulation with Inspire for Untreated Severe Obstructive Sleep Apnoea/Hypopnoea Syndrome: A Simulated Cost-Utility Analysis from a National Health Service Perspective. Blissett, DB., Steier, JS., Karagama, YG., et al.[2021]

In a study of 31 subjects with moderate to severe obstructive sleep apnea, hypoglossal nerve stimulation significantly reduced the severity of the condition, as shown by a decrease in the apnea-hypopnea index from 45.4 to 25.3 events per hour after 12 months.

The treatment was used regularly, averaging 5.4 hours per night, and led to improved sleep quality, with no significant adverse events occurring after the first 6 months, indicating both safety and efficacy of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. Kezirian, EJ., Goding, GS., Malhotra, A., et al.[2022]

Upper airway stimulation (UAS) of the hypoglossal nerve significantly reduced the apnea-hypopnea index (AHI) from 28.6 to 9.5 after 12 months in a study of 60 patients with moderate-to-severe obstructive sleep apnea (OSA).

Patients reported improved sleep quality, as indicated by significant enhancements in the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire, demonstrating that UAS is both a safe and effective treatment option for OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. Steffen, A., Sommer, JU., Hofauer, B., et al.[2022]

In a case series of three pediatric patients with trisomy 21, hypoglossal nerve stimulators (HNS) were successfully used to treat refractory obstructive sleep apnea, resulting in an average improvement of 87.4% in the apnea-hypopnea index (AHI).

The study highlights the importance of careful anesthetic management, including anxiolysis and multimodal analgesia, to ensure safety and effectiveness during the procedure, with no complications reported in the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal Nerve Stimulator Placement for Pediatric Trisomy 21 Patients with Refractory Obstructive Sleep Apnea: A Case Series. Karlik, JB., Raol, N., Gilbertson, L.[2020]

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]

Citations

1. withpower.com withpower.com/trial/phase-sleep-apnea-obstructive-6-2018-3f6c4

Muscle Stimulation for Obstructive Sleep Apnea Upper airway stimulation (UAS) of the hypoglossal nerve significantly reduced the apnea-hypopnea index (AHI) from 28.6 to 9.5 after 12 months in a study of 60 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29582703/

Upper Airway Stimulation for Obstructive Sleep Apnea Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon.

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130008S090b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The IPG detects the patient's respiratory effort and maintains airway patency with mild stimulation of the hypoglossal nerve during inspiration.

4. professionals.inspiresleep.com professionals.inspiresleep.com/en-us/publications/

Publications Explore Inspire's research library for insights into the efficacy of different sleep apnea treatments, long-term results, and factors influencing outcomes.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03844295

Obstructive Sleep Apnea Therapy by Stimulation of the ... Implanted nerve stimulation is a novel therapy for OSA patients that restores the upper airway potency using unilateral XII nerve electric stimulation. The ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/p130008b.pdf

summary of safety and effectiveness data (ssed) It demonstrated that nightly stimulation in patients with moderate to severe obstructive sleep apnea markedly diminished apnea severity without arousing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4434556/

Upper Airway Stimulation for Obstructive Sleep Apnea The trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA.