NCT03707691

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
960

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Nov 2019Oct 2027

First Submitted

Initial submission to the registry

October 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 26, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2027

Last Updated

March 3, 2025

Status Verified

April 1, 2024

Enrollment Period

7.9 years

First QC Date

October 12, 2018

Last Update Submit

February 27, 2025

Conditions

Keywords

HearingCochlear ImplantsCongenital AmusiaPitchAudio-visual interactions

Outcome Measures

Primary Outcomes (4)

  • percentages of correct responses in listening tests

    during procedure

  • reaction times in listening tests

    during procedure

  • Event-Related Fields

    MEG measurements

    during procedure

  • Oscillations

    MEG measurements

    during procedure

Secondary Outcomes (6)

  • percentages of correct responses

    Day 0

  • percentages of correct responses

    Day 0

  • reaction times

    Day 0

  • reaction times

    Day 0

  • Event-Related Fields

    Day 0

  • +1 more secondary outcomes

Study Arms (3)

Cochlear implant users

EXPERIMENTAL

In both arms a pitch training protocol and a visuo-spatial training protocol are applied.

Behavioral: Listening tests. Pitch training protocolBehavioral: visuo-spatial training protocolBehavioral: EEG/MEG/MRI recordings.

Participants with Congenital Amusia

EXPERIMENTAL

In both arms a pitch training protocol and a visuo-spatial training protocol are applied.

Behavioral: Listening tests. Pitch training protocolBehavioral: visuo-spatial training protocolBehavioral: EEG/MEG/MRI recordings.

Control Participants

EXPERIMENTAL
Behavioral: Listening tests. Pitch training protocolBehavioral: visuo-spatial training protocolBehavioral: EEG/MEG/MRI recordings.

Interventions

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.

Cochlear implant usersControl ParticipantsParticipants with Congenital Amusia

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.

Cochlear implant usersControl ParticipantsParticipants with Congenital Amusia

Listening tests. EEG/MEG/MRI recordings

Cochlear implant usersControl ParticipantsParticipants with Congenital Amusia

Eligibility Criteria

Age5 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • For adult participants:
  • Age below 18 or above 90
  • Pregnant or breast-feeding woman
  • For underage participants:
  • \- Pregnant or nursing minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lyon Neuroscience Research Center

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Tune Deafness

Study Officials

  • Anne CACLIN

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 16, 2018

Study Start

November 26, 2019

Primary Completion (Estimated)

October 26, 2027

Study Completion (Estimated)

October 26, 2027

Last Updated

March 3, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations