Sensorineural Hearing LossPULSENCT06013215
Electrical Impulse Parameters and Neuronal Population in the Cochlear Implanted Patient-PULSE
A study testing Cochlear implant (Oticon) stimulation parameter optimization in people with Sensorineural Hearing Loss, run by University Hospital, Tours.
Trial summary
The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- Cochlear implant (Oticon) stimulation parameter optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Nov 2025
- 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
- post-lingually deaf adults with at least one year of cochlear implant experience
- unilateral and bilateral cochlear implant recipients
- Oticon device with Neuro Zti array
- Patient affiliated to french social security
- Consent signed
Who cannot join
- Patients under court protection, guardianship or curatorship
Trial locations and contacts
No sites are listed yet.
About this study
Official title: PULSE - Paramètres de l'Impulsion électrique et Population Neuronale Chez le Patient implanté cochléaire - Etude en Ouvert, Non contrôlé, Non randomisée
The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.
Read the detailed description
The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. Currently, the intensity perceived by the patient is coded by the duration and the amplitude of the electrical impulse but companies have different approaches and fix one of the two parameters for the setting of the processors. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- Cochlear implant (Oticon) stimulation parameter optimization
- Keywords
- hearing loss, cochlear implant, psychoacoustic, charge integration efficiency
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implant (Oticon) stimulation parameter optimizationOther
The pulse amplitude and/or the pulse phase duration will be optimize to improve the intensity resolution of the cochlear implant which may benefit speech perception
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant users with Neuro Zti array | Experimental | Post-lingually cochlear implant users with 12 months of auditory experience Modifications of pulse parameters to determine the charge integration efficiency which is related with neuron survival population Receives: Other: Cochlear implant (Oticon) stimulation parameter optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the charge integration efficiency along the electrodes
Charge integration efficiency will be determined for each electrode by noting the minimum and maximum loudness perceived by the patient as function of pulse phase duration and amplitude
Measured: 4 hours
Secondary outcomes (1)
Questionnaire between Intensity discrimination and charge integration efficiency
3 electrodes that span the range of charge integration efficiency values will be selected as test electrodes. Three intensities will be presented to the patient through the implant and it will be asked to the patient to determine which intensity is higher than the others.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Bakhos, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013215
- Sponsor's protocol ID
- DR230050-PULSE
- Other IDs
- 2023-A00476-39, DR230050
- Acronym
- PULSE
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PULSE - Paramètres de l'Impulsion électrique et Population Neuronale Chez le Patient implanté cochléaire - Etude en Ouvert, Non contrôlé, Non randomisée
- ClinicalTrials.gov ID
- NCT06013215
- Acronym / sponsor ID
- PULSE / DR230050-PULSE
- Conditions
- Sensorineural Hearing Loss
- Keywords
- hearing loss, cochlear implant, psychoacoustic, charge integration efficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 28 Aug 2023 (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 cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.
Detailed description
The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. Currently, the intensity perceived by the patient is coded by the duration and the amplitude of the electrical impulse but companies have different approaches and fix one of the two parameters for the setting of the processors. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant users with Neuro Zti array | Experimental | Other: Cochlear implant (Oticon) stimulation parameter optimizationPost-lingually cochlear implant users with 12 months of auditory experience Modifications of pulse parameters to determine the charge integration efficiency which is related with neuron survival population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- post-lingually deaf adults with at least one year of cochlear implant experience
- unilateral and bilateral cochlear implant recipients
- Oticon device with Neuro Zti array
- Patient affiliated to french social security
- Consent signed
Key exclusion criteria (1 listed)
- Patients under court protection, guardianship or curatorship
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 |
|---|---|---|
| Cochlear implant (Oticon) stimulation parameter optimizationThe pulse amplitude and/or the pulse phase duration will be optimize to improve the intensity resolution of the cochlear implant which may benefit speech perception | Other | Cochlear implant users with Neuro Zti array |
Primary outcome
Calculate the charge integration efficiency along the electrodes
Time frame: 4 hours
Charge integration efficiency will be determined for each electrode by noting the minimum and maximum loudness perceived by the patient as function of pulse phase duration and amplitude
1 secondary outcome
Questionnaire between Intensity discrimination and charge integration efficiency
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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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.
David Bakhos principal investigator
University Hospital, Tours
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear implant (Oticon) stimulation parameter optimization in people with Sensorineural Hearing Loss, run by University Hospital, Tours.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Bakhos, MD, PhD (+33 (0)218370523, bakhos.david@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculate the charge integration efficiency along the electrodes (time frame: 4 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 28 Aug 2023.