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Safety and Performance Study of the Nyxoah SAT System for Treating OSA

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ClinicalTrials.gov Identifier: NCT02312479
Recruitment Status : Terminated
First Posted : December 9, 2014
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Nyxoah S.A.

Brief Summary:
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Nyxoah SAT system Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance Study of the Use of the Nyxoah SAT System for the Treatment of Obstructive Sleep Apnea
Study Start Date : December 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Nyxoah SAT therapy Device: Nyxoah SAT system
The Nyxoah SAT system is comprised of an implantable nerve stimulator implanted over one of the tongue muscles via a minimally invasive procedure. Stimulation of the Hypoglossal nerves causes the tongue muscles to contract, thus maintaining an open airway during sleep.




Primary Outcome Measures :
  1. Incidence of serious device related adverse events [ Time Frame: 6-months post-implantation ]
  2. Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation [ Time Frame: 6-months post-implantation ]


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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with moderate to severe Obstructive Sleep Apnea
  • Have failed or have not tolerated CPAP treatment
  • Willing and capable of providing informed consent
  • Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

Exclusion Criteria:

  • BMI limits
  • Subjects with complete concentric collapse at the soft palate level per endoscopy

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): NCT02312479


Locations
Belgium
Antwerp University Hospital
Edegem, Belgium
Germany
Universitäts-HNO-Klinik Mannheim
Mannheim, Germany
Sponsors and Collaborators
Nyxoah S.A.
Investigators
Principal Investigator: Joachim T Maurer, OA Dr. med. Universitäts-HNO-Klinik Mannheim
Principal Investigator: Evert Hamans, PhD Dr. Universiteit Antwerpen

Responsible Party: Nyxoah S.A.
ClinicalTrials.gov Identifier: NCT02312479     History of Changes
Other Study ID Numbers: SAT2014A
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases