Nerve Stimulation for Obstructive Sleep Apnea

Overseen By Katie Hartley-Estes, RPSGT

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

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for sleep apnea that uses electrical signals to stimulate neck muscles. It targets patients who don't respond well to standard treatments. The goal is to help keep their airways open during sleep by stretching the throat. This new approach offers an alternative for patients who have difficulty using traditional therapies.

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 data supports the effectiveness of the treatment for obstructive sleep apnea?

Research shows that hypoglossal nerve stimulation (HNS) with the Inspire device is effective for people with moderate-to-severe obstructive sleep apnea who cannot use traditional treatments like CPAP (a machine that helps keep the airway open during sleep). Studies have found that this treatment can improve sleep quality and reduce symptoms in these patients. ^{1 2 3 4 5}

Is hypoglossal nerve stimulation safe for humans?

Hypoglossal nerve stimulation (HNS) has been studied for treating obstructive sleep apnea (OSA) and is generally considered safe for adults, with approval from the US Food and Drug Administration. However, there may be concerns about interactions with other devices like cardiac implants, and its use in children is limited. ^{1 3 4 6 7}

How is hypoglossal nerve stimulation different from other treatments for obstructive sleep apnea?

Hypoglossal nerve stimulation (HNS) is unique because it involves surgically implanting a device that stimulates the nerve controlling tongue muscles to keep the airway open during sleep, unlike CPAP machines that use air pressure or surgeries that physically alter airway structures. ^{1 3 4 7 8}

Research Team

David T Kent, M.D.

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2019]

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

Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. [2022]

3. Switzerland 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. [2021]

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

Uvulopalatopharyngoplasty vs CN XII stimulation for treatment of obstructive sleep apnea: A single institution experience. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Insights since FDA Approval of Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Hypoglossal Nerve Stimulator Placement for Pediatric Trisomy 21 Patients with Refractory Obstructive Sleep Apnea: A Case Series. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. [2022]