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出境医 / 临床实验 / Effects of Pulses on Loudness (EfPuL)

Effects of Pulses on Loudness (EfPuL)

Study Description
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").

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sarah CHOUIKH +33493951818 saoh@oticonmedical.com
Contact: Sonia SAAI +33493951818 SOSA@oticonmedical.com

Sponsors and Collaborators
Oticon Medical
Investigators
Layout table for investigator information
Principal Investigator: Christophe VINCENT CHRU Lille
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date July 8, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Pulses on Loudness
Official Title  ICMJE Effects of Parameters of the Electrical Stimulation on Loudness in Oticon Medical Cochlear Implant Patients. Investigational Study for Cochlear Implant Fitting Facilitation
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.
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").
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hearing Loss, Cochlear
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental : experiment 1,2 and 3

One user included participates all experiments:

  • Visit 1 : experiment 1
  • Visit 2 : experiment 2
  • Visit 3 : experiment 3
Interventions:
  • Device: Experiment 1
  • Device: Experiment 2:
  • Device: Experiment 3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2019) 		13
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah CHOUIKH +33493951818 saoh@oticonmedical.com
Contact: Sonia SAAI +33493951818 SOSA@oticonmedical.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04010721
Other Study ID Numbers  ICMJE PIC-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oticon Medical
Study Sponsor  ICMJE Oticon Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christophe VINCENT CHRU Lille
PRS Account Oticon Medical
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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