NCT04031040

Brief Summary

The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.

Trial Health

82
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
54mo left

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
5 countries

19 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Sep 2019Oct 2030

First Submitted

Initial submission to the registry

July 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

7.2 years

First QC Date

July 18, 2019

Last Update Submit

March 2, 2026

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

  • Incidence of device-related Serious Adverse Events (SADEs)

    Incidence of device-related Serious Adverse Events (SADEs)

    12 months post-surgery

  • Change in Apnea-Hypopnea Index from baseline

    Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab

    12 months post-surgery

  • 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)

    12 months post-surgery

Study Arms (1)

Genio® system therapy

EXPERIMENTAL

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.

Device: Genio® system therapy

Interventions

Genio® system therapyDEVICE

Hypoglossal nerve stimulation system

Genio® system therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI) \< 35 kg/m2
  • AHI between 15 to 65 events/hour documented by the closest PSG performed at the time of the patient ICF signature and within maximum 12 months of screening and fulfilling the required technical criteria or during the screening phase.
  • Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.

You may not qualify if:

  • Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment;
  • Taking medication that in the opinion of the Investigator may alter consciousness, the pattern of respiration, or sleep architecture;
  • Major anatomical or functional abnormalities that would impair the ability of the Genio® system to treat OSA;
  • Inadequately treated psychiatric disease that prevent patient compliance with the requirements of the investigational study testing;
  • Life expectancy \< 12 months;
  • Participation in another clinical study (excluding registries) during the study period (3 years).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn

Antwerp, 2170, Belgium

Location

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

Location

CHU - Angers

Angers, 49933, France

Location

Hôpital Henri-Mondor AP-HP

Créteil, 94010, France

Location

Hôpital Privé La Louvière

Lille, 59800, France

Location

Clinique Beau-Soleil

Montpellier, 34070, France

Location

Hôpital Bichat, Assistance Publique - Hôpitaux de Paris

Paris, 75018, France

Location

CEREVES Paris Jean Jaurès - Centre du sommeil

Paris, 75019, France

Location

Hôpital Tenon AP-HP

Paris, 75020, France

Location

Clinique Mutualiste de la Sagesse

Rennes, 35000, France

Location

Polyclinique Saint Laurent

Rennes, 35700, France

Location

CHU Toulouse

Toulouse, 31400, France

Location

Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie

Hamburg, 21075, Germany

Location

HNO-Klinik des Universitätsklinikums Jena

Jena, 07747, Germany

Location

Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum

Mannheim, 68167, Germany

Location

Klinikum rechts der Isar der TU München

München, 81675, Germany

Location

Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie

Wuppertal, 42283, Germany

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1061 AE, Netherlands

Location

Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie

Liestal, 4410, Switzerland

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, MD

    Klinik für HNO-Heilkunde, Mannheim

    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

July 18, 2019

First Posted

July 24, 2019

Study Start

September 1, 2019

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 1, 2030

Last Updated

March 4, 2026

Record last verified: 2026-02

Locations

FR(10)DE(5)NL(1)BE(2)CH(1)