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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
Media Library
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it feasible for me to join this clinical trial at this time?
"115 individuals of ages 22-75 with a diagnosis of obstructive sleep apnea according to their medical history, body mass index within certain limits, and having previously refused or failed positive airway pressure therapies may be eligible for enrollment in this trial. They must also give informed consent before participating."
Answered by AI
Are octogenarians eligible for this research experiment?
"Based on the requirements of this study, individuals must be between 22 and 75 years old to take part."
Answered by AI
How many research centers are administering this experiment?
"14 clinical trial sites are participating in this medical study, including Virginia Commonwealth University (Richmond), The University of Tennessee Health Science Center- Dept. of Otolaryngology (Memphis) and Vanderbilt University Medical Center (Nashville). Additionally, there is a further 11 locations operating for the trials."
Answered by AI
Are there any open recruitment opportunities for this research endeavor?
"The data provided on clinicaltrials.gov reveals that this medical trial is not actively seeking participants; it was initially posted on September 23rd 2020, and most recently updated October 4th 2022. Despite the lack of recruitment for this study, there are 291 other trials which remain open to signing up volunteers."
Answered by AI
Who else is applying?
What state do they live in?
Utah
Georgia
Other
Florida
How old are they?
18 - 65
What site did they apply to?
ENT and Allegy Associates South Florida
University of South Florida-Tampa General Medical Center
University of Iowa- Institute for Clinical & Translational Science
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
What questions have other patients asked about this trial?
Yes. What is the device?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I have tried CPAP for over a year and it has not worked for me. I do not often use the CPAP I have for treatment and looking for alternatives.
PatientReceived 2+ prior treatments
I can't stand having a mask over my face. When I've had surgery, I've asked to have it just off my nose and mouth. I had a sleep study done that said I have severe sleep apnea. My nose plugs up when I lay down.
PatientReceived 1 prior treatment
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