Bilateral Sensorineural Hearing LossNCT05300230
Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users
An observational study of Bilateral Sensorineural Hearing Loss and Unilateral Sensorineural Hearing Loss, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
The aim of this study is to establish the connection between the cochlear implant programming parameters with the auditory effort associated with the speech perception evaluated by pupillometry techniques in different audiometric conditions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bilateral Sensorineural Hearing Loss, Unilateral Sensorineural Hearing Loss
- What is being tested?
- Neuro Zti cochlear implant and Neuro 2 sound processor
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2020to 15 Nov 2022
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated in the Virgen Macarena Hospital of Seville that are users of the Neuro Zti and Neuro 2 processor with at least 6 months of habituation after the implementation.
Who may be able to join
- Users willing to participate in the study with signature and date of the Informed Consent.
- Age between 18 and 70 years old.
- At least 6 months experience with the Neuro Zti implant and Neuro 2 processor.
- Unilateral, bilateral and bimodal users.
- Basic understanding of oral and written Spanish.
- Normal or corrected vision.
Who cannot join
- Speech or language disorder.
- Added comorbidities or cognitive dysfunction.
- Not approval to participate in the study or absence in some of the programmed sessions for the Cochlear Implant.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41013
Amparo Callejón Leblic, amparocallejon@gmail.com
About this study
The aim of this study is to establish the connection between the cochlear implant programming parameters with the auditory effort associated with the speech perception evaluated by pupillometry techniques in different audiometric conditions.
- Being tested
- Neuro Zti cochlear implant and Neuro 2 sound processor
- Keywords
- Bilateral Sensorineural Hearing Loss, Unilateral Sensorineural Hearing Loss, Moderate, Severe, Zti Cochlear implant
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro Zti cochlear implant and Neuro 2 sound processorDevice
The study will consist in 3 visits:
- Visit 1: it will be carried out the first contact and learning the measurement procedure.
- Visit 2: it will be evaluated the speech perception and the measurement of the pupil dilatation in silence and noise conditions.
- Visit 3: it will be analysed the effect of the change in the cochlear implant programming parameters.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Zti Opticon Cochlear Implant | Patients that are users of Neuro Zti and Neuro 2 processor with a minimum of 6 months of habituation after the implementation. Receives: Device: Neuro Zti cochlear implant and Neuro 2 sound processor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the correlation between the speech performance in cochlear implant (CI) users, as measured through the percentage of sentence recognition (%) and the auditory effort, measured by peak pupil dilatation (PPD) in mm.
The speech perception will be evaluated through validated sentence recognition tests (such as the HINT test) and the result will be the percentage of correct sentences repeated by the CI patient. The listening effort will be measured through pupillometry techniques in scenarios with different audiometric conditions (different SNR). The result will be the peak pupil dilation in mm.
Measured: Up to 12 months after the beginning of the study
Secondary outcomes (3)
Evaluate the correlation between the auditory effort as measured through pupillometry techniques and the subjective sensation of the CI patient as rated through validated NASA-TLX questionnaire.
Analyze the correlation between the objetive auditory effort as measured through pupillometry techniques (peak pupil dilatation, PPD in mm) and the subjetive feeling of effort (fatigue, etc.) as rated by the CI patient in NASA-TLX questionnaire.
Measured: Up to 12-24 months after the beginning of the study
Evaluate the correlation between the auditory effort as measured through pupillometry techniques and the cognitive performance of the CI user as measured by different cognitive tests (Nback, Progressive Matrices, Stroop).
Analyze the correlation between the objetive auditory effort as measured through pupillometry techniques (peak pupil dilatation, PPD in mm) and the cognitive performance of the CI patient as measured through cognitive tests (Nback, Progressive Matrices, Stroop)
Measured: Up to 12-24 months after the beginning of the study
Analyze the differences between the auditory effort, as measured through pupillometry techniques in two different CI programming conditions.
Compare the auditory effort made by the CI patients, as measured by pupillometry techniques, i.e., the peak pupil dilatation (PPD in mm) over two different CI programming conditions: the first condition with the noise filter capability of the CI processor in off mode (VoiceTrack OFF) and the second condition with the noise filters in ON mode (VoiceTrack ON)
Measured: Up to 12-36 months after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start15 Mar 2020
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serafín Sánchez Gómez, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300230
- Sponsor's protocol ID
- FIS-ZTI-2019-01
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2020
- Last updated
- 29 Mar 2022
- 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users
- ClinicalTrials.gov ID
- NCT05300230
- Acronym / sponsor ID
- FIS-ZTI-2019-01
- Keywords
- Bilateral Sensorineural Hearing Loss, Unilateral Sensorineural Hearing Loss, Moderate, Severe, Zti Cochlear implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 29 Mar 2022 (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 establish the connection between the cochlear implant programming parameters with the auditory effort associated with the speech perception evaluated by pupillometry techniques in different audiometric conditions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Zti Opticon Cochlear Implant | – | Device: Neuro Zti cochlear implant and Neuro 2 sound processorPatients that are users of Neuro Zti and Neuro 2 processor with a minimum of 6 months of habituation after the implementation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in the Virgen Macarena Hospital of Seville that are users of the Neuro Zti and Neuro 2 processor with at least 6 months of habituation after the implementation.
Key inclusion criteria (6 listed)
- Users willing to participate in the study with signature and date of the Informed Consent.
- Age between 18 and 70 years old.
- At least 6 months experience with the Neuro Zti implant and Neuro 2 processor.
- Unilateral, bilateral and bimodal users.
- Basic understanding of oral and written Spanish.
Key exclusion criteria (3 listed)
- Speech or language disorder.
- Added comorbidities or cognitive dysfunction.
- Not approval to participate in the study or absence in some of the programmed sessions for the Cochlear Implant.
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 |
|---|---|---|
| Neuro Zti cochlear implant and Neuro 2 sound processorThe study will consist in 3 visits: * Visit 1: it will be carried out the first contact and learning the measurement procedure. * Visit 2: it will be evaluated the speech perception and the measurement of the pupil dilatation in silence and noise conditions. * Visit 3: it will be analysed the effect of the change in the cochlear implant programming parameters. | Device | Patients with Zti Opticon Cochlear Implant |
Primary outcome
Analyze the correlation between the speech performance in cochlear implant (CI) users, as measured through the percentage of sentence recognition (%) and the auditory effort, measured by peak pupil dilatation (PPD) in mm.
Time frame: Up to 12 months after the beginning of the study
The speech perception will be evaluated through validated sentence recognition tests (such as the HINT test) and the result will be the percentage of correct sentences repeated by the CI patient. The listening effort will be measured through pupillometry techniques in scenarios with different audiometric conditions (different SNR). The result will be the peak pupil dilation in mm.
3 secondary outcomes
Evaluate the correlation between the auditory effort as measured through pupillometry techniques and the subjective sensation of the CI patient as rated through validated NASA-TLX questionnaire.
Time frame: Up to 12-24 months after the beginning of the study
Evaluate the correlation between the auditory effort as measured through pupillometry techniques and the cognitive performance of the CI user as measured by different cognitive tests (Nback, Progressive Matrices, Stroop).
Time frame: Up to 12-24 months after the beginning of the study
Analyze the differences between the auditory effort, as measured through pupillometry techniques in two different CI programming conditions.
Time frame: Up to 12-36 months after the beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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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.
Serafín Sánchez Gómez principal investigator
Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bilateral Sensorineural Hearing Loss and Unilateral Sensorineural Hearing Loss, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 6 inclusion and 3 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 29 Mar 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amparo Callejón Leblic (955 00 80 00, amparocallejon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the correlation between the speech performance in cochlear implant (CI) users, as measured through the percentage of sentence recognition (%) and the auditory effort, measured by peak pupil dilatation (PPD) in mm. (time frame: Up to 12 months after the beginning of the study). 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 29 Mar 2022.