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Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03868618
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
Nyxoah S.A.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Genio™ system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of device-related SAEs [ Time Frame: 12 months ]
    Incidence of device-related SAEs recorded during the study for a period of 12 months post-surgery.

  2. Change in Apnea Hypopnea Index (AHI4%) [ Time Frame: 12 months ]
    percentage of responders at 12 months based on AHI4

  3. Change in Oxyhemoglobin Desaturation Index (ODI4%) [ Time Frame: 12 months ]
    percentage of responders at 12 months based on ODI4


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868618


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

Locations
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Sponsors and Collaborators
Nyxoah S.A.
Investigators
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Principal Investigator: Tucker Woodson, MD Medical College of Wisconsin
More Information
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Responsible Party: Nyxoah S.A.
ClinicalTrials.gov Identifier: NCT03868618    
Other Study ID Numbers: CL-GEN-002033
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Nyxoah S.A.:
Hypoglossal nerve stimulation
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases