Safety and Performance Study of the Nyxoah SAT System for Treating OSA
NCT ID: NCT02312479
Last Updated: 2016-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2014-12-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nyxoah SAT therapy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects with complete concentric collapse at the soft palate level per endoscopy
21 Years
70 Years
ALL
No
Sponsors
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Nyxoah S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Joachim T Maurer, OA Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Universitäts-HNO-Klinik Mannheim
Evert Hamans, PhD Dr.
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Locations
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Antwerp University Hospital
Edegem, , Belgium
Universitäts-HNO-Klinik Mannheim
Mannheim, , Germany
Countries
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Other Identifiers
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SAT2014A
Identifier Type: -
Identifier Source: org_study_id
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