NCT06086041

Brief Summary

The aim of this study is to display the predictive factors of hearing rehabilitation after cochlear implant surgery in severely to profoundly deaf adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 17, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

July 26, 2023

Last Update Submit

October 10, 2023

Conditions

TractographyCochlear ImplantMagnetic Resonance ImagingHearing RehabilitationHearing Impairment

Keywords

predictive factorsmagnetic resonance imagingcochlear implanthearing rehabilitationhearing impairmenttractography

Outcome Measures

Primary Outcomes (1)

  • Identification of the predictive factors of hearing rehabilitation after cochlear implantation in severely to profoundly deaf adults.

    Correlation between a diffusion MRI biomarker extracted from preoperative brain tractography (fractional anisotropy) and the postoperative hearing performance in silence and noise after cochlear implantation.

    1 year post-surgery

Secondary Outcomes (1)

  • Evaluate the correlation between several predictive factors like clinical parameters, genetics ... with the MRI biomarker.

    3 months, 6 months and 1 year post-surgery.

Study Arms (1)

severely to profoundly deaf patients with cochlear implantation indication

Severely to profoundly deaf patients consulting in Grenoble University Hospital with cochlear implantation indication. Patients are followed according to current care during 1 year after cochlear implantation.

Procedure: cochlear implant

Interventions

cochlear implantPROCEDURE

cochlear implant

severely to profoundly deaf patients with cochlear implantation indication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severely to profoundly deaf patients consulting in Grenoble University Hospital with cochlear implantation indication.

You may qualify if:

  • Patient severely to profoundly deafed according French National Authority for Health (HAS) recommendations followed in Grenoble University Hospital.

You may not qualify if:

  • cochlear malformation making impossible the cochlear implantation
  • IRM contraindications
  • Patient opposed to the use of their data in the context of the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University hospital

Grenoble, 38043, France

RECRUITING

Related Publications (3)

  • Blamey P, Artieres F, Baskent D, Bergeron F, Beynon A, Burke E, Dillier N, Dowell R, Fraysse B, Gallego S, Govaerts PJ, Green K, Huber AM, Kleine-Punte A, Maat B, Marx M, Mawman D, Mosnier I, O'Connor AF, O'Leary S, Rousset A, Schauwers K, Skarzynski H, Skarzynski PH, Sterkers O, Terranti A, Truy E, Van de Heyning P, Venail F, Vincent C, Lazard DS. Factors affecting auditory performance of postlinguistically deaf adults using cochlear implants: an update with 2251 patients. Audiol Neurootol. 2013;18(1):36-47. doi: 10.1159/000343189. Epub 2012 Oct 19.

    PMID: 23095305BACKGROUND

  • Attye A, Renard F, Baciu M, Roger E, Lamalle L, Dehail P, Cassoudesalle H, Calamante F. TractLearn: A geodesic learning framework for quantitative analysis of brain bundles. Neuroimage. 2021 Jun;233:117927. doi: 10.1016/j.neuroimage.2021.117927. Epub 2021 Mar 6.

    PMID: 33689863BACKGROUND

  • Blamey PJ, Pyman BC, Gordon M, Clark GM, Brown AM, Dowell RC, Hollow RD. Factors predicting postoperative sentence scores in postlinguistically deaf adult cochlear implant patients. Ann Otol Rhinol Laryngol. 1992 Apr;101(4):342-8. doi: 10.1177/000348949210100410.

    PMID: 1562140BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Study Officials

  • raphaële QUATRE

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

raphaële QUATRE

CONTACT

0476765616rquatre@chu-grenoble.fr

Gilliane LALAMI

CONTACT

0476766638glalami@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2023

First Posted

October 17, 2023

Study Start

January 17, 2022

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

FR(1)