Muscle Stimulation for Obstructive Sleep Apnea

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Neurologic condition, Egg allergy, Pregnant, Cardiopulmonary conditions, 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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Drug-induced sleep endoscopy (DISE) is a widely used tool for assessing collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. We propose a study examining the physiologic effect of palatoglossus and genioglossus muscle stimulation during DISE.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Grass S88 Muscle Stimulator, Upper Airway Stimulation, Hypoglossal Nerve Stimulation (HNS), Inspire Upper Airway Stimulation for obstructive sleep apnea?

Research shows that hypoglossal nerve stimulation (HNS) is effective for people with moderate-to-severe obstructive sleep apnea who cannot use other treatments like CPAP. Studies report significant improvements in sleep quality and reduced sleep apnea severity after using HNS for 12 months. ^{1 2 3 4 5}

Is hypoglossal nerve stimulation safe for humans?

Hypoglossal nerve stimulation (HNS) has been studied and approved by the US Food and Drug Administration for treating moderate-to-severe obstructive sleep apnea, showing it is generally safe for humans. Studies have assessed its safety and effectiveness, with no major safety concerns reported in the research available. ^{1 3 4 5 6}

How does muscle stimulation treatment for obstructive sleep apnea differ from other treatments?

Muscle stimulation for obstructive sleep apnea, specifically hypoglossal nerve stimulation, is unique because it involves surgically implanting a device that stimulates the nerve controlling tongue muscles to keep the airway open during sleep. This is different from the more common continuous positive airway pressure (CPAP) therapy, which uses a mask to deliver air pressure to keep the airway open. ^{1 2 3 4 7}

Research Team

David T Kent, M.D.

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for adults over 18 with obstructive sleep apnea, confirmed by a sleep study, who can't use CPAP machines comfortably. They must be scheduled for DISE to check their throat structure and agree to research consent. Excluded are those with certain neurological conditions, language barriers, egg allergies, pregnancy, unsafe conditions for sedation or past head/neck surgery or radiation.

Inclusion Criteria

I have been diagnosed with sleep apnea with an AHI of 5 or more.

I am scheduled for a throat examination to assess its structure.

I cannot use CPAP therapy because it's physically or emotionally uncomfortable.

Exclusion Criteria

Unable to consent for research due to language barriers

You have had an allergic reaction to eggs in the past.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo drug-induced sleep endoscopy (DISE) with muscle stimulation using the Grass S88 muscle stimulator

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

2 weeks

Treatment Details

Interventions

• Grass S88 Muscle Stimulator

Trial Overview The study tests the effects of stimulating two muscles in the throat using a Grass S88 Muscle Stimulator during drug-induced sleep endoscopy (DISE). It aims to understand how this stimulation affects airway collapse patterns related to obstructive sleep apnea.

Participant Groups

Group I: Muscle stimulation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

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]

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 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]

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) 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]

References

1. 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]

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. England pubmed.ncbi.nlm.nih.gov

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

4. 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]

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]