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Device
Genio Bilateral Stimulation for Obstructive Sleep Apnea (ACCCESS Trial)
N/A
Recruiting
Research Sponsored by Nyxoah S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe OSA (15≤AHI4≤65 where combined central and mixed AHI<25% of the total AHI) based on a screening HST and confirmed in Baseline PSG.
Complete concentric collapse at the level of the soft palate based on screening DISE.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the duration of the study is expected to be approximately 4.5 years.
Awards & highlights
ACCCESS Trial Summary
This trial shows a safe & effective solution to treat OSA by using a method called Bilateral HGNS.
Who is the study for?
This trial is for adults aged 22-75 with moderate to severe obstructive sleep apnea who haven't had success with or can't tolerate standard treatments like CPAP. Participants should have a BMI ≤ 32 kg/m2, be able to follow the study's requirements, and not be planning pregnancy. Exclusions include prior surgeries affecting the airway, life-threatening diseases, psychiatric conditions that affect compliance, other significant sleep disorders, and substance abuse within the last three years.Check my eligibility
What is being tested?
The Genio System is being tested for its safety and effectiveness in treating patients with complete concentric collapse (CCC) of the upper airway during sleep. The system uses bilateral hypoglossal nerve stimulation (HGNS) as an alternative treatment method for those who struggle with traditional therapies.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical surgical complications such as infection or reaction to anesthesia. There could also be device-specific issues like discomfort at the implant site or unintended nerve stimulation effects.
ACCCESS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe sleep apnea confirmed by tests.
Select...
My sleep study showed complete blockage at the soft palate level.
Select...
I cannot or will not use PAP treatments for my condition.
Select...
I am between 22 and 75 years old and not under legal guardianship.
ACCCESS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the duration of the study is expected to be approximately 4.5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the duration of the study is expected to be approximately 4.5 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint
ACCCESS Trial Design
1Treatment groups
Experimental Treatment
Group I: Genio® 2.1 SystemExperimental Treatment1 Intervention
System Component Genio® System 2.1 Implantable Stimulator (IS) Genio® Implantable Stimulator External Stimulator (ES) Genio® External Stimulator Disposable Patch (DP) Genio® Disposable Patch Activation Chip (AC) Genio® Activation Chip (AC) Model #2364 Charging Unit (CU) Genio® Charging Unit (CU) Model #2238 Sleep Lab Application Genio® Sleep Lab Application Smartphone Application (optional) Genio® Smartphone Application
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Who is running the clinical trial?
Nyxoah Inc.Industry Sponsor
1 Previous Clinical Trials
115 Total Patients Enrolled
Nyxoah S.A.Lead Sponsor
6 Previous Clinical Trials
339 Total Patients Enrolled
Jey Subarroyan, PhDStudy DirectorNyxoah S.A.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a psychiatric condition that stops me from following study procedures.I have moderate to severe sleep apnea confirmed by tests.I do not have major airway or swallowing issues that would affect the Genio® System's effectiveness.You have serious health conditions that make surgery or anesthesia risky, such as severe heart problems, uncontrolled high blood pressure, or certain neurological disorders.My sleep study showed complete blockage at the soft palate level.Your body mass index (BMI) must be 32 or lower.You have a history of using drugs or drinking too much alcohol in the past 3 years.I haven't had surgeries or treatments that could affect a new sleep apnea device.I cannot or will not use PAP treatments for my condition.You are expected to live for less than one year.You have a cricomental space of 0 centimeters or more.I do not have untreated severe sleep issues that could affect sleep study results.I am between 22 and 75 years old and not under legal guardianship.I am on medication that might affect my consciousness or sleep.
Research Study Groups:
This trial has the following groups:- Group 1: Genio® 2.1 System
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment accept participants aged 25 or older?
"This research is seeking out individuals aged between 22 and 75 years old."
Answered by AI
Are there any opportunities to join this clinical trial at the present moment?
"Affirmative. According to clinicaltrials.gov, this health-related research project initially went public on December 28th 2022 and was revised as recently as February 20th 2023. The team is recruiting 124 individuals from 1 medical centre for the trial."
Answered by AI
What is the upper limit of individuals enrolled in this clinical research?
"Affirmative, records hosted on clinicaltrials.gov indicate that this study is actively enrolling participants. This trial was made available to the public first on December 28th 2022 and has been recently amended on February 20th 2023. Currently, a total of 124 individuals are being sought at 1 site for recruitment."
Answered by AI
Is it possible to participate in this clinical trial?
"This trial is seeking 124 adults with obstructive sleep apnea of ages 22 to 75. To be eligible, patients must have a Body Mass Index (BMI) up to 32 kg/m2; an unobstructed cricomental space distance greater than 0 cm; inabilities or refusals towards Positive Airway Pressure treatments; AHI between 15 and 65 combined central and mixed AHI below 25% of the total AHI as determined through Sleep Study screenings; complete concentric collapse at soft palate level based on DISE analysis tests, and finally willing compliance with all study requirements along with follow-up visits, sleep studies,"
Answered by AI
Who else is applying?
What site did they apply to?
University of Miami
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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