Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-02-21 @ 11:19 PM
Study NCT ID:
NCT03048604
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2017-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2017-02-08', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (Incidence of serious device-related adverse events)', 'timeFrame': '6-months post implantation', 'description': 'Incidence of serious device-related adverse events'}, {'measure': 'Performance', 'timeFrame': '6-months post implantation', 'description': 'Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea of Adult']}, 'referencesModule': {'references': [{'pmid': '31601716', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Body mass index ≤32 kg/m2\n* Patients who do not tolerate or do not accept positive airway pressure (PAP) treatments.\n* Obstructive apnoea-hypopnea index (AHI) of 20-60 events/hour\n\nMain Exclusion Criteria:\n\n* Unable or incapable of providing informed written consent\n* Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires\n* Significant co-morbidities making the patient unable or inappropriate to participate in the trial'}, 'identificationModule': {'nctId': 'NCT03048604', 'briefTitle': 'BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nyxoah S.A.'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'BLAST OSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genio(TM) system therapy', 'interventionNames': ['Device: Genio(TM) bilateral hypoglossal nerve stimulation system']}], 'interventions': [{'name': 'Genio(TM) bilateral hypoglossal nerve stimulation system', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Genio(TM) system therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nedlands', 'state': 'Perth', 'country': 'Australia', 'facility': 'Hollywood Private UWA Centre for Sleep Science Facility', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Paris', 'country': 'France', 'facility': 'La Pitié Salpêtrière - Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal National Throat, Nose and Ear Hospital - London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Valérie Attali, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'La Pitié Salpêtrière, Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nyxoah S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}