NCT02204618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

July 28, 2014

Last Update Submit

April 28, 2026

Conditions

Retrocochlear PathologyAuditory Processing Disorder, CentralMajor Cochlear Ossification or Malformation

Keywords

single sided deafnessAsymmetrical hearing lossCost-utilityTinnitusCochlear implantsBone conduction deviceDichotic hearingSquelch effect.

Outcome Measures

Primary Outcomes (1)

  • incremental cost-utility ratio

    6 months after cochlear implantation versus no treatment option

Secondary Outcomes (5)

  • Global score of EuroQoL-5D

    before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6

  • Global score of Nijmegen Cochlear implant Questionnaire (NCIQ)

    before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6

  • Nijmegen Cochlear Implant Questionnaire (NCIQ): score in advanced auditory perception section

    before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6

  • Speech Reception Thresholds

    before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6

  • Mean error angle for sound localization

    before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6

Study Arms (2)

cochlear implantation

EXPERIMENTAL

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

OTHER

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

Interventions

cochlear implantationDEVICE
cochlear implantation
6 months initial abstentionOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse - Pierre Paul Riquet Hospital

Toulouse, Midi-Pyrénées, 31059, France

Location

Related Publications (3)

  • Marx M, Mosnier I, Vincent C, Bonne NX, Bakhos D, Lescanne E, Flament J, Bernardeschi D, Sterkers O, Fraysse B, Lepage B, Godey B, Schmerber S, Uziel A, Mondain M, Venail F, Deguine O. Treatment choice in single-sided deafness and asymmetric hearing loss. A prospective, multicentre cohort study on 155 patients. Clin Otolaryngol. 2021 Jul;46(4):736-743. doi: 10.1111/coa.13672. Epub 2021 Mar 26.

    PMID: 33236413RESULT

  • 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: 30766449RESULT

  • 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.

    PMID: 30352440DERIVED

MeSH Terms

Conditions

Language Development DisordersCongenital AbnormalitiesTinnitus

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation Disorders

Intervention Hierarchy (Ancestors)

Otologic Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativeProsthesis Implantation

Study Officials

  • Mathieu Marx, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 30, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2018

Study Completion

January 1, 2019

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

FR(1)