Effects of Pulses on Loudness
EfPuL
Effects of Parameters of the Electrical Stimulation on Loudness in Oticon Medical Cochlear Implant Patients. Investigational Study for Cochlear Implant Fitting Facilitation
1 other identifier
interventional
20
1 country
1
Brief Summary
The aim of this study is to investigate the effect of varying additional factors on loudness summation in Neuro Zti Cochlear Implant users.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 8, 2019
CompletedStudy Start
First participant enrolled
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2020
CompletedOctober 20, 2021
October 1, 2021
7 months
July 2, 2019
October 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Experiment 2: the effect of number of electrodes on loudness
Changes in electrical charge (nC) needed to achieve C-level and T-level. The charge is the results of Intensity\*Duration of a pulse, in µA and µs respectivelly. If either the amplitude or the duration of the pulse is modified, the charge will be modified as well.
2 hours
Secondary Outcomes (2)
Experiment 1 : the effect of pulse amplitude and pulse duration on loudness
2 hours
Experiment 3 : the effect of stimulation duration on loudness
2 hours
Study Arms (1)
Experimental : experiment 1,2 and 3
OTHEROne user included participates all experiments: * Visit 1 : experiment 1 * Visit 2 : experiment 2 * Visit 3 : experiment 3
Interventions
Stimulation in groups of 4, 8 and 12 electrodes
Eligibility Criteria
You may qualify if:
- Neuro One or Neuro 2 user
- Unilateral or bilateral recipient
- months CI experience to allow for acclimatization to the CI sound processing and pathological changes that could alter the electrode - tissue interface and therefore T- \& C-levels.
- Having at least 7 step sizes on three electrodes in their current clinical map (for experimentation 1).
- Able and willing to provide reliable threshold and comfort level judgements
You may not qualify if:
- Medical conditions that contraindicate the study tests (e.g. tinnitus, dizziness)
- Unrealistic expectations from the candidate regarding the possible benefits, risks, and limitations that are inherent to the device
- Unwillingness or inability of the candidate to comply with all investigational requirements
- Vulnerable population
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
Study Sites (1)
CHU Lille
Lille, 59000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe VINCENT
CHRU LILLE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 8, 2019
Study Start
February 10, 2020
Primary Completion
August 25, 2020
Study Completion
August 25, 2020
Last Updated
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share