Muscle Stimulation for Obstructive Sleep Apnea

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how stimulating certain throat muscles affects sleep apnea, a condition where breathing stops and starts during sleep. Researchers will use a device called the Grass S88 Muscle Stimulator to determine if targeting muscles like the palatoglossus and genioglossus (muscles in the tongue and throat area) can improve breathing during sleep. This trial is ideal for those diagnosed with obstructive sleep apnea who cannot comfortably use CPAP machines and are already scheduled for a type of sleep assessment. As an unphased trial, it offers patients the opportunity to contribute to innovative research that could lead to new treatment options for sleep apnea.

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 prior data suggests that this muscle stimulation is safe for obstructive sleep apnea?

Research shows that muscle stimulation for treating obstructive sleep apnea is generally safe and well-tolerated. Studies have found that stimulating the hypoglossal nerve, which controls tongue movements, can significantly reduce sleep apnea symptoms. This therapy often results in fewer breathing interruptions during sleep.

Serious side effects are rare, according to past research. Some studies tracked participants for up to five years and found improvements in sleepiness and quality of life. While serious unexpected negative effects are uncommon, they can still occur.

In summary, previous studies suggest that muscle stimulation for sleep apnea is usually safe for most people. However, like any treatment, there's always a small chance of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for obstructive sleep apnea, which often include CPAP machines or oral appliances, the Grass S88 muscle stimulator offers a novel approach by directly targeting muscle activity. This device uses electrical stimulation to engage throat muscles, potentially reducing airway obstruction during sleep. Researchers are excited about this method because it might provide a non-invasive alternative that doesn't require wearing bulky equipment while sleeping, offering more comfort and convenience for patients.

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

Research has shown that stimulating the hypoglossal nerve, which controls certain throat muscles, can greatly reduce the severity of obstructive sleep apnea (OSA). One study found that patients experienced a reduction in sleep disruption, as measured by the apnea-hypopnea index (AHI), from 28.6 to 9.5 over a year. This approach also improved sleepiness, quality of life, and breathing over five years, with few serious side effects. In this trial, participants will receive the Grass S88 Muscle Stimulator, which helps keep the airway open during sleep by activating specific throat muscles. This method shows promise for people with OSA, as it addresses the main cause of their breathing problems. ^{1 3 4 5 6}

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 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 am scheduled for a throat examination to assess its structure.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

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 the Grass S88 muscle stimulator.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

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]

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]

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 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) 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]

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.

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.

5.

withpower.com

withpower.com/trial/phase-sleep-apnea-syndromes-7-2022-e2f18

Nerve 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 ...

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 ...