Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-28 @ 10:31 AM
Study NCT ID:
NCT02204618
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2014-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007805', 'term': 'Language Development Disorders'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019929', 'term': 'Cochlear Implantation'}], 'ancestors': [{'id': 'D013506', 'term': 'Otologic Surgical Procedures'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2014-07-28', 'studyFirstSubmitQcDate': '2014-07-29', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incremental cost-utility ratio', 'timeFrame': '6 months after cochlear implantation versus no treatment option'}], 'secondaryOutcomes': [{'measure': 'Global score of EuroQoL-5D', 'timeFrame': 'before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6'}, {'measure': 'Global score of Nijmegen Cochlear implant Questionnaire (NCIQ)', 'timeFrame': 'before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6'}, {'measure': 'Nijmegen Cochlear Implant Questionnaire (NCIQ): score in advanced auditory perception section', 'timeFrame': 'before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6'}, {'measure': 'Speech Reception Thresholds', 'timeFrame': 'before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6', 'description': 'Signal to noise ratio that allows 50% words recognition) in diotic hearing, dichotic hearing and reverse dichotic hearing'}, {'measure': 'Mean error angle for sound localization', 'timeFrame': 'before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['single sided deafness', 'Asymmetrical hearing loss', 'Cost-utility', 'Tinnitus', 'Cochlear implants', 'Bone conduction device', 'Dichotic hearing', 'Squelch effect.'], 'conditions': ['Retrocochlear Pathology', 'Auditory Processing Disorder, Central', 'Major Cochlear Ossification or Malformation']}, 'referencesModule': {'references': [{'pmid': '18834065', 'type': 'BACKGROUND', 'citation': 'Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, De Ridder D. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol Laryngol. 2008 Sep;117(9):645-52. doi: 10.1177/000348940811700903.'}, {'pmid': '23358584', 'type': 'BACKGROUND', 'citation': 'Plontke SK, Heider C, Koesling S, Hess S, Bieseke L, Goetze G, Rahne T. Cochlear implantation in a child with posttraumatic single-sided deafness. Eur Arch Otorhinolaryngol. 2013 May;270(5):1757-61. doi: 10.1007/s00405-013-2350-2. Epub 2013 Jan 29.'}, {'pmid': '19005250', 'type': 'BACKGROUND', 'citation': 'Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13.'}, {'pmid': '21756468', 'type': 'BACKGROUND', 'citation': 'Punte AK, Vermeire K, Hofkens A, De Bodt M, De Ridder D, Van de Heyning P. Cochlear implantation as a durable tinnitus treatment in single-sided deafness. Cochlear Implants Int. 2011 May;12 Suppl 1:S26-9. doi: 10.1179/146701011X13001035752336.'}, {'pmid': '22723876', 'type': 'BACKGROUND', 'citation': 'Lazard DS, Marozeau J, McDermott HJ. The sound sensation of apical electric stimulation in cochlear implant recipients with contralateral residual hearing. PLoS One. 2012;7(6):e38687. doi: 10.1371/journal.pone.0038687. Epub 2012 Jun 19.'}, {'pmid': '11568669', 'type': 'BACKGROUND', 'citation': 'Persson P, Harder H, Arlinger S, Magnuson B. Speech recognition in background noise: monaural versus binaural listening conditions in normal-hearing patients. Otol Neurotol. 2001 Sep;22(5):625-30. doi: 10.1097/00129492-200109000-00011.'}, {'pmid': '4038669', 'type': 'BACKGROUND', 'citation': 'Bess FH. The minimally hearing-impaired child. Ear Hear. 1985 Jan-Feb;6(1):43-7. doi: 10.1097/00003446-198501000-00012.'}, {'pmid': '3227285', 'type': 'BACKGROUND', 'citation': 'Bovo R, Martini A, Agnoletto M, Beghi A, Carmignoto D, Milani M, Zangaglia AM. Auditory and academic performance of children with unilateral hearing loss. Scand Audiol Suppl. 1988;30:71-4.'}, {'pmid': '15148171', 'type': 'BACKGROUND', 'citation': 'Lieu JE. Speech-language and educational consequences of unilateral hearing loss in children. Arch Otolaryngol Head Neck Surg. 2004 May;130(5):524-30. doi: 10.1001/archotol.130.5.524.'}, {'pmid': '6074893', 'type': 'BACKGROUND', 'citation': 'Giolas TG, Wark DJ. Communication problems associated with unilateral hearing loss. J Speech Hear Disord. 1967 Nov;32(4):336-43. doi: 10.1044/jshd.3204.336. No abstract available.'}, {'pmid': '10777019', 'type': 'BACKGROUND', 'citation': 'Dalzell L, Orlando M, MacDonald M, Berg A, Bradley M, Cacace A, Campbell D, DeCristofaro J, Gravel J, Greenberg E, Gross S, Pinheiro J, Regan J, Spivak L, Stevens F, Prieve B. The New York State universal newborn hearing screening demonstration project: ages of hearing loss identification, hearing aid fitting, and enrollment in early intervention. Ear Hear. 2000 Apr;21(2):118-30. doi: 10.1097/00003446-200004000-00006.'}, {'pmid': '21940980', 'type': 'BACKGROUND', 'citation': 'Chapman DA, Stampfel CC, Bodurtha JN, Dodson KM, Pandya A, Lynch KB, Kirby RS. Impact of co-occurring birth defects on the timing of newborn hearing screening and diagnosis. Am J Audiol. 2011 Dec;20(2):132-9. doi: 10.1044/1059-0889(2011/10-0049). Epub 2011 Sep 22.'}, {'pmid': '6325838', 'type': 'BACKGROUND', 'citation': "Byl FM Jr. Sudden hearing loss: eight years' experience and suggested prognostic table. Laryngoscope. 1984 May;94(5 Pt 1):647-61."}, {'pmid': '21068690', 'type': 'BACKGROUND', 'citation': 'Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271.'}, {'pmid': '22935813', 'type': 'BACKGROUND', 'citation': 'Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d.'}, {'pmid': '23202150', 'type': 'BACKGROUND', 'citation': 'Hassepass F, Aschendorff A, Wesarg T, Kroger S, Laszig R, Beck RL, Schild C, Arndt S. Unilateral deafness in children: audiologic and subjective assessment of hearing ability after cochlear implantation. Otol Neurotol. 2013 Jan;34(1):53-60. doi: 10.1097/MAO.0b013e31827850f0.'}, {'pmid': '20014322', 'type': 'BACKGROUND', 'citation': 'Bishop CE, Eby TL. The current status of audiologic rehabilitation for profound unilateral sensorineural hearing loss. Laryngoscope. 2010 Mar;120(3):552-6. doi: 10.1002/lary.20735.'}, {'pmid': '8275169', 'type': 'BACKGROUND', 'citation': 'Essink-Bot ML, Stouthard ME, Bonsel GJ. Generalizability of valuations on health states collected with the EuroQolc-questionnaire. Health Econ. 1993 Oct;2(3):237-46. doi: 10.1002/hec.4730020307.'}, {'pmid': '21935715', 'type': 'BACKGROUND', 'citation': 'Chevalier J, de Pouvourville G. Valuing EQ-5D using time trade-off in France. Eur J Health Econ. 2013 Feb;14(1):57-66. doi: 10.1007/s10198-011-0351-x. Epub 2011 Sep 21.'}, {'pmid': '23429927', 'type': 'BACKGROUND', 'citation': 'Gaylor JM, Raman G, Chung M, Lee J, Rao M, Lau J, Poe DS. Cochlear implantation in adults: a systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg. 2013 Mar;139(3):265-72. doi: 10.1001/jamaoto.2013.1744.'}, {'type': 'BACKGROUND', 'citation': "Drummond M, O' brien B, Stodart G et al. 1998. Méthodes d'évaluation économique des programmes de santé. Paris : Economica, 1998."}, {'pmid': '30766449', 'type': 'RESULT', 'citation': 'Marx M, Costa N, Lepage B, Taoui S, Molinier L, Deguine O, Fraysse B. Cochlear implantation as a treatment for single-sided deafness and asymmetric hearing loss: a randomized controlled evaluation of cost-utility. BMC Ear Nose Throat Disord. 2019 Feb 4;19:1. doi: 10.1186/s12901-019-0066-7. eCollection 2019.'}, {'pmid': '30352440', 'type': 'DERIVED', 'citation': 'Dorbeau C, Galvin J, Fu QJ, Legris E, Marx M, Bakhos D. Binaural Perception in Single-Sided Deaf Cochlear Implant Users with Unrestricted or Restricted Acoustic Hearing in the Non-Implanted Ear. Audiol Neurootol. 2018;23(3):187-197. doi: 10.1159/000490879. Epub 2018 Oct 23.'}]}, 'descriptionModule': {'briefSummary': "The investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A comparative cost-utility analysis between the two arms, of medical consequences measured in terms of quality of life will identify a preference for a strategy. Specific binaural hearing measurements with respect to each treatment option (abstention, CROS, bone conduction device, cochlear implant) will also be collected.", 'detailedDescription': "Single sided deafness and profound asymmetrical hearing loss are impairments that significantly alter quality of life. Behavioural problems and scholar delays have been reported in children. Speech recognition with background or competing noise and sound localization are both impaired. 1/1000 new borns are affected and the incidence tends to rise in the adult population. At the moment, there is no guideline regarding the treatment of single sided deafness and asymmetrical hearing loss. Some patients don't even receive any therapeutic proposition.\n\nThree treatment options are available :\n\n* CROS (Contralateral Routing Of the Signal) systems that convey the auditory information from the deaf ear to the good ear using wi-fi\n* bone conduction devices which use transcranial conduction to convey auditory information from the poor ear to the good ear\n* cochlear implants that directly stimulate afferent fibers of auditory nerve in the poor ear Cochlear implantation is therefore the only treatment which restores stimulation in the poor ear. Its efficacy in single sided deafness associated with incapacitating tinnitus have been demonstrated by Pr Van de Heyning (Leeuven, Be) and colleagues. Its interest has been compared to CROS systems and bone conduction devices in a valuable study conducted by S. Arndt (Pr Laszig, Freibourg, Ger). Cochlear implants provided better speech in noise recognition scores in dichotic hearing, i.e when speech and noise sources are spatially separated. Their first publication involved 11 patients but to date, more than 110 patients with single sided deafness have been included in their protocol. The efficacy of cochlear implantation has thus been validated in the treatment of single sided deafness and asymmetrical hearing loss.\n\nThe investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A comparative cost-utility analysis between the two arms, of medical consequences measured in terms of quality of life will identify a preference for a strategy. Specific binaural hearing measurements with respect to each treatment option (abstention, CROS, bone conduction device, cochlear implant) will also be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Social security affiliation\n* Single sided deafness or profound asymmetrical hearing loss confirmed using pure tone audiometry and auditory brainstem responses, with or without tinnitus\n* Written consent to the protocol\n\nExclusion Criteria:\n\n* Retrocochlear pathology (vestibular schwannoma, severe central auditory processing disorder)\n* Major cochlear ossification or malformation\n* Subjects under juridical protections or tutelage measure'}, 'identificationModule': {'nctId': 'NCT02204618', 'acronym': 'CISSD', 'briefTitle': 'Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.', 'orgStudyIdInfo': {'id': '13 7053 10'}, 'secondaryIdInfos': [{'id': 'PRME2013', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cochlear implantation', 'description': 'Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).', 'interventionNames': ['Device: cochlear implantation']}, {'type': 'OTHER', 'label': '6 months initial abstention', 'description': 'Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).', 'interventionNames': ['Other: 6 months initial abstention']}], 'interventions': [{'name': 'cochlear implantation', 'type': 'DEVICE', 'armGroupLabels': ['cochlear implantation']}, {'name': '6 months initial abstention', 'type': 'OTHER', 'description': 'Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).', 'armGroupLabels': ['6 months initial abstention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': 'University Hospital of Toulouse - Pierre Paul Riquet Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Mathieu Marx, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}