Brief description of trial (Data source: BASEC)
Cette étude nous permettra d’investiguer si l’ajout de différents intervalles de temps dans la stimulation cochléaire à un impact sur la performance auditive (reconnaissance des sons du langage). Le but final est d’évaluer la stratégie de stimulation cochléaire qui sera utilisée dans des futurs processeurs vocales des implants cochléaires et cochléo-vestibulaires.
Health conditions investigated(Data source: BASEC)
Surdité sévère a profonde réhabilité par implant cochléaire.
Health conditions
(Data source: WHO)
Deafness;Hearing Loss
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Implant cochléaire
Interventions
(Data source: WHO)
Other: Cochlear stimulation strategy including time-fixed gaps
Criteria for participation in trial
(Data source: BASEC)
- Patients porteurs d'implant cochléaire MED-EL (type C40+, Pulsar, SONATA, Concerto ou SYNCHRONY)
- Minimum de 9 électrodes actives de type Standard, FLEXSOFT, FLEX28 ou FLEX24
Exclusion criteria
(Data source: BASEC)
- Patients qui utilisent un système électroacoustique (EAS)
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Informed Consent as documented by signature
- CI recipients using MED-EL implants (C40+, Pulsar, Sonata, Concerto, or Synchrony) and
standard electrode arrays (Standard, FLEXSOFT, FLEX28, or FLEX24)
- >1 year post-implantation
- Regular CI use (at least 4 hours/day)
- At least 9 active electrodes in the device
- Good knowledge of French (at least B1 level according to the Common European Framework
of Reference for Languages)
Exclusion Criteria:
- Patients with electro-acoustic stimulation (EAS) systems
- Unwillingness or inability to perform investigational tests
- Known or suspected drug or alcohol abuse
- Inability to follow the procedures of the study (e.g. due to language problems,
psychological disorders, dementia, etc.)
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent
persons
-
Further information on trial
Date trial registered
Apr 30, 2019
Incorporation of the first participant
Mar 6, 2019
Recruitment status
Completed
Academic title
(Data source: WHO)
Effect of Gap-interleaved Stimulation Paradigms in Speech Perception Performance of Experienced Cochlear Implant Recipients: a Single-centre, Randomised Controlled Single-blinded Study
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Performance in standardized speech perception tests
Secundary end point
(Data source: WHO)
Comparison of volume levels resulting in equal loudness perception
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
No
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Geneva
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Angelica Perez Fornos
+41 22 372 28 46
angelica.perez-fornos@hcuge.ch
Contact for general information
(Data source: WHO)
Angelica Perez Fornos, PhD
University Hospital, Geneva
Contact for scientific information
(Data source: WHO)
Angelica Perez Fornos, PhD
University Hospital, Geneva
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Commission Cantonale
d’éthique de la recherche Genève (CCER)
Date of authorisation by the ethics committee
22.01.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2018-01938
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