Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.
NCT ID: NCT02204618
Last Updated: 2020-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2014-10-31
2019-01-31
Brief Summary
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Detailed Description
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Three treatment options are available :
* CROS (Contralateral Routing Of the Signal) systems that convey the auditory information from the deaf ear to the good ear using wi-fi
* bone conduction devices which use transcranial conduction to convey auditory information from the poor ear to the good ear
* 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.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cochlear implantation
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).
cochlear implantation
6 months initial abstention
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).
6 months initial abstention
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).
Interventions
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cochlear implantation
6 months initial abstention
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).
Eligibility Criteria
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Inclusion Criteria
* Single sided deafness or profound asymmetrical hearing loss confirmed using pure tone audiometry and auditory brainstem responses, with or without tinnitus
* Written consent to the protocol
Exclusion Criteria
* Major cochlear ossification or malformation
* Subjects under juridical protections or tutelage measure
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Mathieu Marx, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Toulouse
Locations
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University Hospital of Toulouse - Pierre Paul Riquet Hospital
Toulouse, Midi-Pyrénées, France
Countries
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References
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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.
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.
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.
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.
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.
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.
Bess FH. The minimally hearing-impaired child. Ear Hear. 1985 Jan-Feb;6(1):43-7. doi: 10.1097/00003446-198501000-00012.
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.
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.
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.
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.
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.
Byl FM Jr. Sudden hearing loss: eight years' experience and suggested prognostic table. Laryngoscope. 1984 May;94(5 Pt 1):647-61.
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.
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.
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.
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.
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.
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.
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.
Drummond M, O' brien B, Stodart G et al. 1998. Méthodes d'évaluation économique des programmes de santé. Paris : Economica, 1998.
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.
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.
Other Identifiers
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PRME2013
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
13 7053 10
Identifier Type: -
Identifier Source: org_study_id
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