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

NCT02312479 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-09-27

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Nyxoah S.A.

    lead INDUSTRY

Principal Investigators

  • Joachim T Maurer, OA Dr. med. · Universitäts-HNO-Klinik Mannheim

  • Evert Hamans, PhD Dr. · Universiteit Antwerpen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-11-30
Completion
2016-04-30

Countries

  • Belgium
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02312479 on ClinicalTrials.gov