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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
DREAM Trial 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.Check my eligibility
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.See study design
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.
DREAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot or will not use PAP treatments for my condition.
DREAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Apnea Hypopnea Index (AHI4%)
Change in Oxyhemoglobin Desaturation Index (ODI4%)
Incidence of device-related SAEs
DREAM 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I likely have moderate to severe sleep apnea based on my medical history.I have health conditions that make surgery or anesthesia risky for me.I am willing and able to agree to the study's procedures.I cannot or will not use PAP treatments for my condition.Your body weight is either too low or too high for this study.I have sleep disorders other than OSA that are not well-managed.
Research Study Groups:
This trial has the following groups:- Group 1: Genio Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT03868618 — N/A
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