Back to results

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

Primary Purpose

Obstructive Sleep Apnea

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Nyxoah SAT system

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Antwerp University Hospital
Universitäts-HNO-Klinik Mannheim

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nyxoah SAT therapy

Arm Description

Outcomes

Primary Outcome Measures

Incidence of serious device related adverse events

Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation

Secondary Outcome Measures

Full Information

NCT ID

NCT02312479

First Posted

December 4, 2014

Last Updated

September 26, 2016

Sponsor

Nyxoah S.A.

1. Study Identification

Unique Protocol Identification Number

NCT02312479

Brief Title

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

Official Title

Safety and Performance Study of the Use of the Nyxoah SAT System for the Treatment of Obstructive Sleep Apnea

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Study Start Date

December 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nyxoah S.A.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nyxoah SAT therapy

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Nyxoah SAT system

Intervention Description

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 Measure Information:

Title

Incidence of serious device related adverse events

Time Frame

6-months post-implantation

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joachim T Maurer, OA Dr. med.

Organizational Affiliation

Universitäts-HNO-Klinik Mannheim

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Evert Hamans, PhD Dr.

Organizational Affiliation

Universiteit Antwerpen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Antwerp University Hospital

City

Edegem

Country

Belgium

Facility Name

Universitäts-HNO-Klinik Mannheim

City

Mannheim

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs