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Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study. (CISSD)

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ClinicalTrials.gov Identifier: NCT02204618
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Retrocochlear Pathology Auditory Processing Disorder, Central Major Cochlear Ossification or Malformation Device: cochlear implantation Other: 6 months initial abstention Not Applicable

Detailed Description:

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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.
Actual Study Start Date : October 2014
Actual Primary Completion Date : April 2018
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Device: 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).
Other: 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).




Primary Outcome Measures :
  1. incremental cost-utility ratio [ Time Frame: 6 months after cochlear implantation versus no treatment option ]

Secondary Outcome Measures :
  1. Global score of EuroQoL-5D [ Time Frame: before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6 ]
  2. Global score of Nijmegen Cochlear implant Questionnaire (NCIQ) [ Time Frame: before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6 ]
  3. Nijmegen Cochlear Implant Questionnaire (NCIQ): score in advanced auditory perception section [ Time Frame: before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6 ]
  4. Speech Reception Thresholds [ Time Frame: before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6 ]
    Signal to noise ratio that allows 50% words recognition) in diotic hearing, dichotic hearing and reverse dichotic hearing

  5. Mean error angle for sound localization [ Time Frame: before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Social security affiliation
  • 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:

  • Retrocochlear pathology (vestibular schwannoma, severe central auditory processing disorder)
  • Major cochlear ossification or malformation
  • Subjects under juridical protections or tutelage measure

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): NCT02204618


Locations
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France
University Hospital of Toulouse - Pierre Paul Riquet Hospital
Toulouse, Midi-Pyrénées, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Mathieu Marx, MD University Hospital of Toulouse
Publications of Results:
Other Publications:
Drummond M, O' brien B, Stodart G et al. 1998. Méthodes d'évaluation économique des programmes de santé. Paris : Economica, 1998.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02204618    
Other Study ID Numbers: 13 7053 10
PRME2013 ( Other Grant/Funding Number: Ministry of Health )
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Keywords provided by University Hospital, Toulouse:
single sided deafness
Asymmetrical hearing loss
Cost-utility
Tinnitus
Cochlear implants
Bone conduction device
Dichotic hearing
Squelch effect.
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Auditory Perceptual Disorders
Language Development Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Auditory Diseases, Central
Retrocochlear Diseases
Brain Diseases
Central Nervous System Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Language Disorders
Communication Disorders