Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients

Deafness Clinical Trial

— NEUROSYLLABIC  

Official title:

Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323256
• Other study ID #: 2014.857
• Secondary ID: 2014-A00345-42
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: May 2018

Study information

• Verified date: September 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

Inclusion Criteria:

• native French speaker

• no medical treatment for behavior or neurological disorders

• normal or corrected vision

• right-handed

• normal ORL examination

• valid affiliation to social security

• absence of participation to another study

For the cochlear implanted patients:

• aged from 1 to 70

• bilateral severe to profound deafness

• cochlear implant

• congenital deafness, pre or post lingual

For the normal-hearing subjects:

• Aged from 18 to 70

• Normal tonal audiometry

Exclusion Criteria:

• No signed consent

• Treatment for depression, epilepsy, Parkinson's or Alzheimer's disease

• Physical health deficiency

• Mental retardation

• Neurological or psychiatric disease incompatible with the testing procedure

• Schooling in a foreign language

• Foreign language spoken at home with both parents

• Invalid social security

• For the normal hearing subjects, no known hearing deficits

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Other:
• Auditory steady-state response ASSR
comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities
• Speech-ABR

• Acoustic Change Complex ACC
comparison of ACC complex in response to changes within speech stimulation
• P1-N1-P2 complex and Mismatch Negativity MMN
comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hopital Edouard Herriot	Lyon

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	Amplitude of auditory steady state responses ASSR		one year at least after CI activation
Primary	Spectro-temporal analysis of speech-ABR		one year at least after CI activation
Primary	Acoustic Change Complex ACC	Amplitudes and latencies of ACC	one year at least after CI activation
Primary	amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN		one year at least after CI activation
Primary	Evolution of amplitude of auditory steady state responses ASSR	Evolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients	1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Primary	Evolution of spectro-temporal analysis of speech-ABR	Evolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients	1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Primary	Acoustic Change Complex ACC	Evolution of amplitudes and latencies of ACC as a function of time during the first year of CI activation in newly implanted patients	1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Primary	amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN	Evolution of amplitudes and latencies of P1N1P2 and MMN as a function of time during the first year of CI activation in newly implanted patients	1 month, 3 months, 6 months, 9 months and 12 months after CI activation