Nerve Stimulation Device for Obstructive Sleep Apnea

(DREAM Trial)

Not currently recruiting at 21 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the Genio™ system, a device designed to help people with obstructive sleep apnea (OSA) breathe better while sleeping. The device stimulates a nerve in the tongue to keep airways open. It is ideal for those with moderate to severe OSA who have not succeeded with other treatments like positive airway pressure (PAP) therapy. Participants should be adults who have faced challenges with current sleep apnea treatments. As an unphased trial, this study provides an opportunity to explore a new treatment option for those struggling with existing therapies.

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 prior data suggests that the Genio system is safe for treating obstructive sleep apnea?

Research has shown that the Genio™ system for treating obstructive sleep apnea is generally safe. The FDA has approved it for patients with moderate to severe cases, indicating it has undergone testing and meets safety standards. Studies indicate that patients tolerate the treatment well, especially those who struggle with other common treatments like CPAP. Reports from previous studies show that the benefits of the treatment outweigh potential risks. These studies also note that unwanted effects are rare and usually minor. Most patients find the treatment satisfactory and safe. This information suggests that the Genio™ system is a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Genio™ system is unique because it offers a new approach to managing obstructive sleep apnea by using neurostimulation. Unlike traditional treatments like CPAP machines, which require wearing a mask during sleep, the Genio™ system involves an implantable device that stimulates the nerves controlling the tongue to keep airways open. Researchers are excited about this treatment because it provides a less intrusive solution that might improve patient comfort and adherence, potentially leading to better long-term outcomes. Plus, this nerve stimulation technique targets the root cause of the airway blockage, offering a promising alternative to conventional therapies.

What evidence suggests that the Genio system is effective for obstructive sleep apnea?

Research has shown that the Genio™ system, which participants in this trial will receive, effectively treats obstructive sleep apnea. In one study, participants experienced a median reduction of 70.8% in their apnea-hypopnea index (AHI), a measure of how often breathing is disrupted during sleep. Notably, 82% of participants achieved an AHI below 15, indicating significant improvement. The Genio™ system stimulates the nerves that help keep the airway open during sleep. This technology has consistently proven effective, regardless of sleeping position, making it a promising option for those with sleep apnea. ^{1 2 4 6 7}

Who Is on the Research Team?

Tucker Woodson, M.D.

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240024B.pdf

SSED Template - accessdata.fda.gov SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED). I. GENERAL INFORMATION. Device Generic Name: Genio® System for Obstructive Sleep Apnea (OSA).

2. aasm.org aasm.org/nyxoah-receives-fda-approval-for-genio-system/

Nyxoah receives FDA approval for Genio system Participants experienced a median AHI reduction of 70.8%, and 82% achieved an AHI below 15. The results showed Genio was effective regardless of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05592002

NCT05592002 | Safety and Effectiveness of the Genio® ... The solution offered by the Genio System to treat OSA patients with CCC using bilateral HGNS has a favorable risk-benefit ratio, as demonstrated by evidence ...

4. neurologyadvisor.com neurologyadvisor.com/news/fda-clears-genio-system-for-obstructive-sleep-apnea/

FDA Clears Genio System for Obstructive Sleep Apnea “This unique bilateral stimulation technology has demonstrated consistent efficacy across all sleeping positions, including the challenging ...

5. nyxoah.gcs-web.com nyxoah.gcs-web.com/news-releases/news-release-details/nyxoahs-dream-pivotal-study-data-published-journal-clinical

Nyxoah's DREAM Pivotal Study Data Published in the Journal ... “The DREAM study demonstrated efficacy of bilateral hypoglossal nerve stimulation using Genio for the treatment of obstructive sleep apnea," ...

6. geniosleep.com geniosleep.com/

Genio® by Nyxoah Genio is an FDA-approved, mask-free treatment option for moderate to severe Obstructive Sleep Apnea (OSA). Genio therapy works by gently stimulating hypoglossal ...

7. withpower.com withpower.com/trial/phase-sleep-apnea-syndromes-9-2022-04a44

Genio Bilateral Stimulation for Obstructive Sleep Apnea · ... Additionally, the treatment is considered safe and satisfactory for patients, especially those who cannot use other common treatments like CPAP. Overall, the ...