NCT02312479

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

December 4, 2014

Last Update Submit

September 26, 2016

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Incidence of serious device related adverse events

    6-months post-implantation

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

    6-months post-implantation

Study Arms (1)

Nyxoah SAT therapy

EXPERIMENTAL
Device: Nyxoah SAT system

Interventions

Nyxoah SAT systemDEVICE

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.

Nyxoah SAT therapy

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Antwerp University Hospital

Edegem, Belgium

Location

Universitäts-HNO-Klinik Mannheim

Mannheim, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Joachim T Maurer, OA Dr. med.

    Universitäts-HNO-Klinik Mannheim

    PRINCIPAL INVESTIGATOR

  • Evert Hamans, PhD Dr.

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 9, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

April 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

BE(1)DE(1)