NCT03048604

Brief Summary

The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
3 countries

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

February 7, 2017

Last Update Submit

October 7, 2021

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (2)

  • Safety (Incidence of serious device-related adverse events)

    Incidence of serious device-related adverse events

    6-months post implantation

  • Performance

    Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI)

    6-months post implantation

Study Arms (1)

Genio(TM) system therapy

EXPERIMENTAL
Device: Genio(TM) bilateral hypoglossal nerve stimulation system

Interventions

Genio(TM) bilateral hypoglossal nerve stimulation systemDEVICE

Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Four (4) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4 and 6 month(s) after implantation.

Genio(TM) system therapy

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index ≤32 kg/m2
  • Patients who do not tolerate or do not accept positive airway pressure (PAP) treatments.
  • Obstructive apnoea-hypopnea index (AHI) of 20-60 events/hour

You may not qualify if:

  • Unable or incapable of providing informed written consent
  • Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
  • Significant co-morbidities making the patient unable or inappropriate to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hollywood Private UWA Centre for Sleep Science Facility

Nedlands, Perth, Australia

Location

La Pitié Salpêtrière - Paris

Paris, France

Location

Royal National Throat, Nose and Ear Hospital - London

London, United Kingdom

Location

Related Publications (1)

  • Eastwood PR, Barnes M, MacKay SG, Wheatley JR, Hillman DR, Nguyen XL, Lewis R, Campbell MC, Petelle B, Walsh JH, Jones AC, Palme CE, Bizon A, Meslier N, Bertolus C, Maddison KJ, Laccourreye L, Raux G, Denoncin K, Attali V, Gagnadoux F, Launois SH. Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eur Respir J. 2020 Jan 9;55(1):1901320. doi: 10.1183/13993003.01320-2019. Print 2020 Jan.

    PMID: 31601716DERIVED

Study Officials

  • Valérie Attali, Dr.

    La Pitié Salpêtrière, Paris

    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

February 7, 2017

First Posted

February 9, 2017

Study Start

March 30, 2017

Primary Completion

September 10, 2018

Study Completion

September 10, 2018

Last Updated

October 11, 2021

Record last verified: 2021-10

Locations

AU(1)GB(1)FR(1)