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BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03048604
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Nyxoah S.A.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Adult Device: Genio(TM) bilateral hypoglossal nerve stimulation system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Prospective, Open-label, Non-randomized, Single Arm Treatment Study to Assess the Safety, Performance and Initial Efficacy Trends of the Genio(TM) Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea.
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: Genio(TM) system therapy Device: Genio(TM) bilateral hypoglossal nerve stimulation system
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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety (Incidence of serious device-related adverse events) [ Time Frame: 6-months post implantation ]
    Incidence of serious device-related adverse events

  2. Performance [ Time Frame: 6-months post implantation ]
    Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • 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

Main Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048604


Locations
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Australia, Perth
Hollywood Private UWA Centre for Sleep Science Facility
Nedlands, Perth, Australia
France
La Pitié Salpêtrière - Paris
Paris, France
United Kingdom
Royal National Throat, Nose and Ear Hospital - London
London, United Kingdom
Sponsors and Collaborators
Nyxoah S.A.
Investigators
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Principal Investigator: Valérie Attali, Dr. La Pitié Salpêtrière, Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nyxoah S.A.
ClinicalTrials.gov Identifier: NCT03048604    
Other Study ID Numbers: BLAST OSA
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases