Pitch and Loudness Perception by Cochlear Implant Listeners: Psychophysics and Objective Measures

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284790
First received: January 21, 2011
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people worldwide. While most patients show good scores of speech recognition in quiet, a large majority of them also struggle in more challenging listening situations, such as speech in noise or music. This project aims to understand the basic mechanisms of electrical stimulation of the auditory nerve, in order to identify the important cues that the electrical signal should convey and to possible improve sound perception by CI users.


Condition Intervention
Cochlear Implant Listeners
Device: Cochlear implants

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pitch and Loudness Perception by Cochlear Implant Listeners: Psychophysics and Objective Measures

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Identify waveforms aimed to improve sound perception by CI recipients [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To correlate the results of our measures psychophysiques with recordings électrophysiologiques of the neuronal activity of the hearing nerve. [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cochlear implants Device: Cochlear implants

Detailed Description:

This study will take place in the ENT department of La Timone hospital in Marseille, where more than 120 adults have been implanted. Our study will comprise several phases, including (1) temporal coding of pitch, (2) spatial coding of pitch, and (3) loudness perception. Eight adult implant users will be recruited for each of these phases.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The adults of more than 18 years old at the beginning of the study without notion of minimal or maximal duration of setting-up(presence).
  • The adults WITH cochlear implant listeners .

Exclusion Criteria:

  • Presence of intrusive disorders of the personality or mental deficiency. Presence of associated driving disorders. Pregnant or breast-feeding woman.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284790

Contacts
Contact: STEPHANE ROMAN 04 91 38 60 81 stephane.roman@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: STEPHANE ROMAN       stephane.roman@ap-hm.fr   
Principal Investigator: stephane ROMAN         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: direction de la recherche, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
ClinicalTrials.gov Identifier: NCT01284790     History of Changes
Other Study ID Numbers: 2010-A00439-30, 2009-35
Study First Received: January 21, 2011
Last Updated: September 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on July 24, 2014