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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03707691
Other study ID # 69HCL18_0632
Secondary ID 2018-A02670-55
Status Recruiting
Phase N/A
First received
Last updated
Start date November 26, 2019
Est. completion date October 26, 2025

Study information

Verified date April 2024
Source Hospices Civils de Lyon
Contact Anne CACLIN
Phone 4 72 13 89 04
Email anne.caclin@inserm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pitch perception and memory are central in auditory cognition, in particular for sound source segregation and recognition, speech prosody and music processing. Here the investigator assess pitch perception and memory in hearing-impaired listeners wearing cochlear implant(s) and listeners with congenital amusia, both compared with control listeners. Behavioral, EEG, and MEG measures are collected in audio and audio-visual contexts to characterize pitch processing deficits, and test a pitch training program.


Recruitment information / eligibility

Status Recruiting
Enrollment 960
Est. completion date October 26, 2025
Est. primary completion date October 26, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 90 Years
Eligibility Inclusion Criteria: For adult participants: - Aged between 18 and 90 - Absence of neurological and psychiatric disorders - No major cognitive deficit, ability to understand and apply study instructions - Motivation to participate efficiently in the study - Written informed consent to participant in the study - Affiliated to social security - Control participants and participants with congenital amusia for Experiment 5: MRI/MEG compatibility For underage participants: - Subject aged 5 years and over - Informed consent of parents or guardians for the participation of the child being studied - No neurological or psychiatric history - Without major cognitive impairment and ability to understand and apply setpoint. - Subject affiliated to a social security scheme - Motivation to participate effectively in the project Exclusion Criteria: For adult participants: - Age below 18 or above 90 - Pregnant or breast-feeding woman For underage participants: - Pregnant or nursing minors

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Listening tests. Pitch training protocol
The two training protocols consists of perceptual tasks (auditory or visual exercises) performed repetitively using a tablet. Each protocol consists in 30 sessions of ~20 minutes performed at home over a period of 15 weeks.
visuo-spatial training protocol
The two training protocols consists of perceptual tasks (auditory or visual exercises) performed repetitively using a tablet. Each protocol consists in 30 sessions of ~20 minutes performed at home over a period of 15 weeks.
EEG/MEG/MRI recordings.
Listening tests. EEG/MEG/MRI recordings

Locations

Country Name City State
France Lyon Neuroscience Research Center Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary percentages of correct responses in listening tests during procedure
Primary reaction times in listening tests during procedure
Primary Event-Related Fields MEG measurements during procedure
Primary Oscillations MEG measurements during procedure
Secondary percentages of correct responses Performance in listening tests in audio contexts Day 0
Secondary percentages of correct responses Performance in listening tests in audio-visual contexts Day 0
Secondary reaction times Performance in listening tests in audio contexts Day 0
Secondary reaction times Performance in listening tests in audio-visual contexts Day 0
Secondary Event-Related Fields EEG measurements Day 0
Secondary Oscillations EEG measurements Day 0
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