Purpose

A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.

Condition

Eligibility

Eligible Ages
Between 22 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Body mass index (BMI) limitations - Likely suffer from moderate to severe OSA based on history and physical - Has either not tolerated, has failed or refused positive airway pressure (PAP) treatments - Willing and capable of providing informed consent

Exclusion Criteria

  • Inadequately treated sleep disorders other than OSA - Significant co-morbidities that contraindicates surgery or general anesthesia

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Genio Therapy
The Genio™ system is an implantable neurostimulation system comprised of one implanted device
  • Device: Genio™ system
    The Genio™ device is a permanent implant. It is implanted in the chin area and delivers stimulation to both hypoglossal nerve branches (i.e., the left and right branches). The implant does not include a battery or an embedded software and is externally powered.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Kate Von Wahlde
625-322-0333
kate.vonwahlde@vumc.org

More Details

Status
Recruiting
Sponsor
Nyxoah S.A.

Study Contact

Jey Subbaroyan, PhD
+1 (734) 277-3273
Jey.Subbaroyan@Nyxoah.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.