Hearing Loss, CochlearEfPuLNCT04010721
Effects of Pulses on Loudness
A study testing Experiment 1, Experiment 2: and Experiment 3 in people with Hearing Loss, Cochlear, run by Oticon Medical at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Cochlear
- What is being tested?
- Experiment 1, Experiment 2: and Experiment 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2020to 25 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Parameters of the Electrical Stimulation on Loudness in Oticon Medical Cochlear Implant Patients. Investigational Study for Cochlear Implant Fitting Facilitation
The aim of this study is to investigate the effect of varying additional factors on loudness summation in Neuro Zti Cochlear Implant users.
Read the 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").
- Conditions
- Hearing Loss, Cochlear
- Being tested
- Experiment 1, Experiment 2:, Experiment 3
- Keywords
- Cochlear implant
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiment 1Device
Stimulation of one electrode at a time
Experiment 2:Device
Stimulation in groups of 4, 8 and 12 electrodes
Experiment 3Device
Stimulation total duration from 10 to 600 ms
| Study group | Role | What they receive |
|---|---|---|
| Experimental : experiment 1,2 and 3 | Other | One user included participates all experiments:
* Visit 1 : experiment 1
* Visit 2 : experiment 2
* Visit 3 : experiment 3 Receives: Device: Experiment 1; Device: Experiment 2:; Device: Experiment 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (2)
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.
Measured: 2 hours
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start10 Feb 2020
- Primary completion25 Aug 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, CochlearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe VINCENT, Principal investigator, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010721
- Sponsor's protocol ID
- PIC-19
- Acronym
- EfPuL
- Status last verified
- Oct 2021
- First submitted
- 2 Jul 2019
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parameters of the Electrical Stimulation on Loudness in Oticon Medical Cochlear Implant Patients. Investigational Study for Cochlear Implant Fitting Facilitation
- ClinicalTrials.gov ID
- NCT04010721
- Acronym / sponsor ID
- EfPuL / PIC-19
- Conditions
- Hearing Loss, Cochlear
- Keywords
- Cochlear implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental : experiment 1,2 and 3 | Other | Device: Experiment 1, Device: Experiment 2:, Device: Experiment 3One user included participates all experiments: * Visit 1 : experiment 1 * Visit 2 : experiment 2 * Visit 3 : experiment 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experiment 1Stimulation of one electrode at a time | Device | Experimental : experiment 1,2 and 3 |
| Experiment 2:Stimulation in groups of 4, 8 and 12 electrodes | Device | Experimental : experiment 1,2 and 3 |
| Experiment 3Stimulation total duration from 10 to 600 ms | Device | Experimental : experiment 1,2 and 3 |
Primary outcome
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.
2 secondary outcomes
Experiment 1 : the effect of pulse amplitude and pulse duration on loudness
Time frame: 2 hours
Experiment 3 : the effect of stimulation duration on loudness
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe VINCENT principal investigator
CHRU LILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experiment 1, Experiment 2: and Experiment 3 in people with Hearing Loss, Cochlear, run by Oticon Medical at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiment 2: the effect of number of electrodes on loudness (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.