Effects of Pulses on Loudness

Hearing Loss, Cochlear Clinical Trial

— EfPuL  

Official title:

Effects of Parameters of the Electrical Stimulation on Loudness in Oticon Medical Cochlear Implant Patients. Investigational Study for Cochlear Implant Fitting Facilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010721
• Other study ID #: PIC-19
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: August 25, 2020

Study information

• Verified date: October 2021
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effect of varying additional factors on loudness summation in Neuro Zti Cochlear Implant users.

Description:

Primary objective: - To assess the effect of the number and spatial distribution of active electrodes on the stimulation charge required to achieve the loudness associated with C and T levels (Experiment 2). Secondary objectives: - To assess how loudness is affected by changes in electrical charge of individual pulses made by adjusting the pulse amplitude versus adjusting pulse duration (Experiment 1). - To assess how loudness elicited by a train of pulses is affected by the duration of that pulse train (Experiment 3). Experiment 1: The test will investigate the effect of loudness on changes in electrical charge of individual pulses, made by separately adjusting pulse amplitude or pulse width. The electrical charge required to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable") either when increasing the amplitude or the duration of the pulses. Experiment 2: The test will investigate the effect of the number of stimulating electrodes and their distribution within the cochlea on the stimulation levels required to achieve T-levels and C-levels and to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable"). Experiment 3: The test will investigate the effect on loudness of trains of pulses elicited by modifications to the duration of those trains, when operating around T and C levels. Stimulation durations ranging from 10 to 600 ms will be tested. Pulse trains will be presented to either one or several electrodes to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 25, 2020
• Est. primary completion date: August 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Neuro One or Neuro 2 user
• Unilateral or bilateral recipient
• 12 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Cochlear
• Hearing Loss, Sensorineural

Intervention

Device:
• Experiment 1
Stimulation of one electrode at a time
• Experiment 2:
Stimulation in groups of 4, 8 and 12 electrodes
• Experiment 3
Stimulation total duration from 10 to 600 ms

Locations

Country	Name	City	State
France	CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Experiment 1 : the effect of pulse amplitude and pulse duration on loudness	Change of the charge (nC) required to elicit different loudness. 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	Experiment 3 : the effect of stimulation duration on loudness	Change of the charge (nC) to elicit th most comfortable loudness (C-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