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Effects of Pulses on Loudness (EfPuL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010721
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Cochlear Device: Experiment 1 Device: Experiment 2: Device: Experiment 3 Not Applicable

Detailed 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").

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Parameters of the Electrical Stimulation on Loudness in Oticon Medical Cochlear Implant Patients. Investigational Study for Cochlear Implant Fitting Facilitation
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental : experiment 1,2 and 3

One user included participates all experiments:

  • Visit 1 : experiment 1
  • Visit 2 : experiment 2
  • Visit 3 : experiment 3
Device: Experiment 1
Stimulation of one electrode at a time

Device: Experiment 2:
Stimulation in groups of 4, 8 and 12 electrodes

Device: Experiment 3
Stimulation total duration from 10 to 600 ms




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010721


Contacts
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Contact: Sarah CHOUIKH +33493951818 saoh@oticonmedical.com
Contact: Sonia SAAI +33493951818 SOSA@oticonmedical.com

Sponsors and Collaborators
Oticon Medical
Investigators
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Principal Investigator: Christophe VINCENT CHRU Lille
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Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT04010721    
Other Study ID Numbers: PIC-19
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oticon Medical:
Cochlear implant
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms