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Hypoglossal Nerve Stimulation

Nerve Stimulation Device for Obstructive Sleep Apnea (DREAM Trial)

N/A
Waitlist Available
Led By Tucker Woodson, MD
Research Sponsored by Nyxoah S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has either not tolerated, has failed or refused positive airway pressure (PAP) treatments
Be older than 18 years old
Must not have
Significant co-morbidities that contraindicates surgery or general anesthesia
Inadequately treated sleep disorders other than OSA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new device to treat sleep apnea. The device stimulates the nerves that control the tongue to keep the airway open during sleep.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, similar nerve stimulation devices may cause discomfort at the implant site, changes in tongue movement, throat sensations, or speech changes. General risks associated with surgery and anesthesia also apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I cannot or will not use PAP treatments for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have health conditions that make surgery or anesthesia risky for me.
Select...
I have sleep disorders other than OSA that are not well-managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Apnea Hypopnea Index (AHI4%)
Change in Oxyhemoglobin Desaturation Index (ODI4%)
Incidence of device-related SAEs
Secondary study objectives
AHI4
ESS
FOSQ-10
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Genio TherapyExperimental Treatment1 Intervention
The Genio™ system is an implantable neurostimulation system comprised of one implanted device

Find a Location

Who is running the clinical trial?

Nyxoah Inc.Industry Sponsor
1 Previous Clinical Trials
124 Total Patients Enrolled
Nyxoah, Inc.UNKNOWN
Nyxoah S.A.Lead Sponsor
6 Previous Clinical Trials
348 Total Patients Enrolled

Media Library

Genio™ system (Hypoglossal Nerve Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03868618 — N/A
Obstructive Sleep Apnea Research Study Groups: Genio Therapy
Obstructive Sleep Apnea Clinical Trial 2023: Genio™ system Highlights & Side Effects. Trial Name: NCT03868618 — N/A
Genio™ system (Hypoglossal Nerve Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03868618 — N/A
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT03868618 — N/A
~23 spots leftby Nov 2025
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