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Completed

NCT Number: NCT04010721

Effects of Pulses on Loudness

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

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Key information

Conditions

Hearing Loss, Cochlear Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Lille

Lille, 59000, France

About this study

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").

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experiment 1

Device

Stimulation of one electrode at a time

Experiment 2:

Device

Stimulation in groups of 4, 8 and 12 electrodes

Experiment 3

Device

Stimulation total duration from 10 to 600 ms

Primary outcomes

  1. Experiment 2: the effect of number of electrodes on loudness

    Time frame: 2 hours

    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.

Secondary outcomes

  1. Experiment 1 : the effect of pulse amplitude and pulse duration on loudness

    Time frame: 2 hours

    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. Experiment 3 : the effect of stimulation duration on loudness

    Time frame: 2 hours

    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.

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

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

Acronym: EfPuL

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2019
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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