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OpenTrials
Completed

NCT Number: NCT02904187

Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults

The primary objective to this study is to describe bilateral auditory information processing in profoundly deaf patients with bilateral cochlear implants compared with normal hearing patients. Assumption used is that due to the central consequences of bilateral deafness on binaural auditory information central processing, time between activation of the two cochlear implants is a decisive factor in bilateral implantation compared to unilateral implantation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département d'ORL, Hôpital Edouard Herriot

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients:

  • profoundly deaf patients with bilateral cochlear implants

Exclusion criteria

for patients:

  • post-operative complications
  • incomplete surgical insertion of one of the cochlear implant
  • age under 18 years
  • non-compliant patient
  • pregnant woman or woman with no efficient contraception method
  • informed consent not signed
  • no health insurance

Inclusion criteria

for control

  • normal hearing subjects

Exclusion criteria

control

  • normal hearing subject
  • subject under 18 years old
  • unilateral or bilateral hearing loss
  • non-compliant subject
  • pregnant woman or woman with no efficient contraception method
  • informed consent not signed
  • no health insurance

Treatment and study plan

Positron Emission Tomography (PET)

Other

Electroencephalogram (EEG)

Other

Primary outcomes

  1. Cortical brain activation pattern

    Time frame: 6 months

    Cortical brain activation pattern obtained by PET or EEG cartography. Activation pattern will be compared between normal hearing subjects and deaf adults with bilateral cochlear implants

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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