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A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults (EliSA)

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Genio(TM) system therapy
Sponsored by
Nyxoah S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body Mass Index (BMI) < 35 kg/m2
  • AHI between 15 to 65 events/hour documented by a PSG during the screening phase.
  • Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.

Exclusion Criteria:

  • Night shift worker
  • Significant comorbidities that contraindicates surgery
  • Life expectancy < 12 months
  • Participation in another clinical study (excluding registries) during the study period (3 years).

Sites / Locations

  • Ziekenhuis Netwerk Antwerpen - ZNA Jan PalfijnRecruiting
  • Universitair Ziekenhuis AntwerpenRecruiting
  • CHU - Angers
  • Centre Hospitalier Intercommunal de Créteil
  • Hôpital Henri-Mondor AP-HP
  • Hôpital Privé La Louvière
  • Clinique Beau-Soleil
  • Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
  • CEREVES Paris Jean Jaurès - Centre du sommeil
  • Hôpital Tenon AP-HP
  • CHU - Poitiers
  • Clinique Mutualiste de la Sagesse
  • Polyclinique Saint Laurent
  • CHU Toulouse
  • Klinik für Hals-, Nasen-, Ohrenheilkunde der Charité am Standort CCM Charité - Universitätsmedizin Berlin
  • Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und HalschirurgieRecruiting
  • HNO-Klinik des Universitätsklinikums JenaRecruiting
  • Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches ZentrumRecruiting
  • Klinikum rechts der Isar der TU MünchenRecruiting
  • Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde Universitätsklinikum Regensburg
  • Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
  • Onze Lieve Vrouwe GasthuisRecruiting
  • Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und GesichtschirurgieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Genio(TM) system therapy

Arm Description

Following activation of the Genio™ system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery.

Outcomes

Primary Outcome Measures

Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs)
Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs) reported during the study
Change in Apnea-Hypopnea Index from baseline
Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ)

Secondary Outcome Measures

Full Information

First Posted
July 18, 2019
Last Updated
January 10, 2022
Sponsor
Nyxoah S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04031040
Brief Title
A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults
Acronym
EliSA
Official Title
A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nyxoah S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.
Detailed Description
This study is a multicenter, prospective single arm PMCF. Following activation of the Genio™ system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.

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
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genio(TM) system therapy
Arm Type
Experimental
Arm Description
Following activation of the Genio™ system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery.
Intervention Type
Device
Intervention Name(s)
Genio(TM) system therapy
Intervention Description
Hypoglossal nerve stimulation system
Primary Outcome Measure Information:
Title
Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs)
Description
Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs) reported during the study
Time Frame
12 months post-surgery
Title
Change in Apnea-Hypopnea Index from baseline
Description
Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab
Time Frame
12 months post-surgery
Title
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire
Description
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ)
Time Frame
12 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body Mass Index (BMI) < 35 kg/m2 AHI between 15 to 65 events/hour documented by a PSG during the screening phase. Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments. Exclusion Criteria: Night shift worker Significant comorbidities that contraindicates surgery Life expectancy < 12 months Participation in another clinical study (excluding registries) during the study period (3 years).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jey Subbaroyan, PhD
Phone
+1 (734) 277-3273
Email
Jey.Subbaroyan@Nyxoah.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim T. Maurer, MD
Organizational Affiliation
Klinik für HNO-Heilkunde, Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
City
Antwerp
ZIP/Postal Code
2170
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Email
evert.hamans@zna.be
First Name & Middle Initial & Last Name & Degree
Evert Hamans, Dr.
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Email
olivier.Vanderveken@uza.be
First Name & Middle Initial & Last Name & Degree
Olivier Vanderveken, Prof.
Facility Name
CHU - Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Suspended
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Suspended
Facility Name
Hôpital Henri-Mondor AP-HP
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Suspended
Facility Name
Hôpital Privé La Louvière
City
Lille
ZIP/Postal Code
59800
Country
France
Individual Site Status
Suspended
Facility Name
Clinique Beau-Soleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
Individual Site Status
Suspended
Facility Name
Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Suspended
Facility Name
CEREVES Paris Jean Jaurès - Centre du sommeil
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Suspended
Facility Name
Hôpital Tenon AP-HP
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Suspended
Facility Name
CHU - Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Suspended
Facility Name
Clinique Mutualiste de la Sagesse
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Suspended
Facility Name
Polyclinique Saint Laurent
City
Rennes
ZIP/Postal Code
35700
Country
France
Individual Site Status
Suspended
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Suspended
Facility Name
Klinik für Hals-, Nasen-, Ohrenheilkunde der Charité am Standort CCM Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
Email
philipp.arens@charite.de
First Name & Middle Initial & Last Name & Degree
Philipp Arens, Dr. med.
Facility Name
Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
t.verse@asklepios.com
First Name & Middle Initial & Last Name & Degree
Thomas Verse, Prof. Dr. med.
Facility Name
HNO-Klinik des Universitätsklinikums Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
gerlind.schneider@med.uni-jena.de
First Name & Middle Initial & Last Name & Degree
Gerlind Schneider, Dr.
Facility Name
Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
joachim.maurer@umm.de
First Name & Middle Initial & Last Name & Degree
Joachim T. Maurer, Prof. Dr.
Facility Name
Klinikum rechts der Isar der TU München
City
München
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
clemens.heiser@tum.de
First Name & Middle Initial & Last Name & Degree
Clemens Heiser, Prof. Dr. med.
Facility Name
Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
Email
rene.fischer@ukr.de
First Name & Middle Initial & Last Name & Degree
René Fischer, Dr. med.
Facility Name
Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Email
n.vries@olvg.nl
First Name & Middle Initial & Last Name & Degree
Nicolaas de Vries, Prof.
Facility Name
Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie
City
Liestal
ZIP/Postal Code
4410
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
Email
Kurt.Tschopp@ksbl.ch
First Name & Middle Initial & Last Name & Degree
Kurt Tschopp, Prof. Dr.

12. IPD Sharing Statement

Learn more about this trial

A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults

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