Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users

Bilateral Sensorineural Hearing Loss Clinical Trial

Official title:

Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300230
• Other study ID #: FIS-ZTI-2019-01
• Status: Recruiting
• Start date: March 15, 2020
• Est. completion date: November 15, 2022

Study information

• Verified date: March 2022
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Amparo Callejón Leblic
• Phone: 955 00 80 00
• Email: amparocallejon[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bilateral Sensorineural Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• Neuro Zti cochlear implant and Neuro 2 sound processor
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months after the beginning of the study
Secondary	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.	Up to 12-24 months after the beginning of the study
Secondary	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)	Up to 12-24 months after the beginning of the study
Secondary	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)	Up to 12-36 months after the beginning of the study