Nerve Stimulation Device for Obstructive Sleep Apnea

(DREAM Trial)

Recruiting at 20 trial locations

Overseen By Tod C Huntley, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nyxoah S.A.

Must not be taking: Consciousness-altering, Respiratory-altering, Sleep-altering

Disqualifiers: Severe insomnia, Narcolepsy, Night shift work, Major anatomical abnormalities, Significant comorbidities, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

115 Participants Needed

Trial Summary

What is the purpose of this trial?

A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it excludes those taking medications that may alter consciousness, breathing patterns, or sleep structure. It's best to discuss your specific medications with the trial investigator.

What data supports the effectiveness of the Genio™ system treatment for obstructive sleep apnea?

Research shows that hypoglossal nerve stimulation, like the Genio™ system, can reduce the severity of obstructive sleep apnea by activating muscles that keep the airway open. Studies on similar devices have demonstrated significant improvements in sleep apnea symptoms, suggesting that the Genio™ system may also be effective. ^{1 2 3 4 5}

Is the nerve stimulation device for obstructive sleep apnea safe for humans?

Research shows that the Genio™ system, a nerve stimulation device for obstructive sleep apnea, is generally safe for humans. Studies report no need for surgical revision and improvements in sleep without significant safety concerns. ^{1 2 4 5 6}

How is the Genio™ system treatment different from other treatments for obstructive sleep apnea?

The Genio™ system is unique because it uses a small implanted electrode to stimulate the hypoglossal nerve (a nerve that controls tongue movement) bilaterally, which helps keep the airway open during sleep. Unlike the standard CPAP (continuous positive airway pressure) therapy, which requires wearing a mask, this device is activated by an external unit and does not require a mask, making it a less intrusive option for patients. ^{1 2 3 7 8}

Research Team

Tucker Woodson, M.D.

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for adults with moderate to severe obstructive sleep apnea who haven't had success with or can't tolerate positive airway pressure treatments. Participants should have a certain body mass index (BMI) and be able to give informed consent. Those with other untreated sleep disorders or conditions that make surgery or anesthesia risky cannot join.

Inclusion Criteria

I likely have moderate to severe sleep apnea based on my medical history.

I am willing and able to agree to the study's procedures.

I cannot or will not use PAP treatments for my condition.

Exclusion Criteria

I have health conditions that make surgery or anesthesia risky for me.

I have sleep disorders other than OSA that are not well-managed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Genio dual-sided hypoglossal nerve stimulation system

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Genio™ system

Trial Overview The study is evaluating the safety and effectiveness of the Genio system, which stimulates both sides of the hypoglossal nerve as a treatment for obstructive sleep apnea. It's conducted across multiple centers where participants will receive this new intervention.

Participant Groups

Group I: Genio Therapy Experimental Treatment 1 Intervention

The Genio™ system is an implantable neurostimulation system comprised of one implanted device

Who Is Running the Clinical Trial?

Nyxoah S.A.

Lead Sponsor

Trials

7

Recruited

460+

Nyxoah Inc.

Industry Sponsor

Trials

2

Recruited

240+

Nyxoah, Inc.

Collaborator

Trials

1

Recruited

120+

Findings from Research

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]

The bilateral hypoglossal nerve stimulator (Genio system) was successfully implanted in a 60-year-old woman with moderate obstructive sleep apnea, showing no complications during surgery and recovery.

After 6 months, the device significantly reduced apnea and hypopnea events by 88% and improved oxygen saturation levels from 78% to 91%, indicating its efficacy in treating obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea. Lewis, R., Pételle, B., Campbell, MC., et al.[2022]

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]

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]

Hypoglossal nerve stimulation (HNS) is an effective treatment for obstructive sleep apnea (OSA) by increasing the muscle tone of the genioglossus muscle, which helps keep the airway open.

Breathing synchronized HNS has shown strong safety and efficacy results, while newer continuous and bilateral HNS methods are emerging with promising but limited data, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea]. Maurer, JT., Troia, R., Leitzbach, S.[2021]

In a study of 30 patients with sleep apnea, hypoglossal nerve stimulation (HGNS) significantly increased airflow during sleep, demonstrating a clear dose-dependent response without waking the patients.

HGNS effectively eliminated inspiratory airflow limitation (IFL) in 57% of patients, indicating its potential efficacy in treating various severities of sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute upper airway responses to hypoglossal nerve stimulation during sleep in obstructive sleep apnea. Schwartz, AR., Barnes, M., Hillman, D., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Upper Airway Stimulation in OSA]. [2018]

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

Intraoral Neuromuscular Stimulation Device and Rapid Eye Movement-Dependent Obstructive Sleep Apnea. [2022]

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

Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial. [2023]

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

Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea]. [2021]

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

Acute upper airway responses to hypoglossal nerve stimulation during sleep in obstructive sleep apnea. [2021]