About this trial
Aims: To evaluate the perception and enjoyment of music in cochlear implant (CI) users using specific questionnaires, and comparing their results with a control group of subjects with normal hearing (NH). To analyze the musical abilities of implantees using the musical tool Meludia, and compare the results with the control group. To perfom a voice analysis in implanted patients, compare it with their NH peers, and check if an association with musical perception is observed.
Design: Cross-sectional study, both the CI recipients and NH control subjects were assessed once.
Setting and subjects: Pre-or perilingual patients aged 6 to 17 years old, and postlingual adults who underwent cochlear implantation from 2000 to January 2023 at La Paz University Hospital. Control group is set up with their NH peers.
Study Variables: Socio-demographic and clinical (current age, age at implantation, sex, educational level) variables will be collected, as well as hearing loss (aetiology, duration of deafness), and surgical (type of implant, complete or partial insertion of the electrodes, date of surgery) data. Data from CI fitting (number of active electrodes, type of audio processor) and hearing outcomes with the CI will also be reviewed.
Outcome variables: Specific musical skills questionnaires for adults: Munich Music Questionnaire (MuMu) and Music Related Quality of Life Questionnaire (MuRQoL), which will be validated. Musical questionnaire developed specifically for subjects between 6-17 years old. Musical tool (Meludia) to assess musical perception. Praat software for voice analysis. Analysis of the impact of the different audiological, sociodemographic and clinical variables on hearing outcomes, and on musical perception after cochlear implantation, and comparison with the NH control group.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Minimum age of 6 years.
Patients aged 6-17 years must have been implanted before the age of 3 years (to ensure adequate CI performance).
Minimum 12 months experience with the device
Indications: unilateral (one CI), bilateral (two CIs), bimodal (one CI in one ear and a hearing aid in the other)
Disqualifiers
Not meet inclusion criteria.
Prelingual or perilingual adults.
Disability in addition to hearing impairment (e.g., mental disability).
Trial population
Adult patients (≥18 years) with postlingual hearing loss and children (between 6 and 17 years) with prelingual or perilingual hearing loss who have received a CI before the age of 3 years. Patients who have received a CI from 2000 to January 2023 will be included as potential candidates for participation
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
evaluation with Meludia music software
Other interventionMeasurement instruments: 1. \- MuMu Questionnaire 2. MuRQoL Questionnaire 3. Questionnaire for subjects aged 6-17 years 4. Music tool Meludia (www.meludia.com) 5. Acoustic analysis of the voice: the Praat programme 6. Audiological tests
Treatment groups
Trial outcomes
Primary outcomes
Scoring on a specific musical questionnaire for adults: MuMu
Change in the musical experience and degree of enjoyment of music before and after CI in adult (≥18 years) post-lingual patients with the Munich Music Questionnaire (MuMu).
Scoring on a specific musical questionnaire for adults: MuRQoL
Change in music perception with the Music Related Quality of Life (MuRQoL) questionnaire in postlingually hearing adults (≥18 years) with CI and compare it with the results in subjects with normal hearing.
Translation and validation the MuRQoL questionnaire in Spanish.
Translation of the MuRQoL questionnaire: Initially, the questionnaire will be translated from English to Spanish by a suitably qualified person. This will be followed by translation from Spanish to English (back-translation) by another qualified person from outside the clinical study. This will ensure that the Spanish version faithfully reproduces the original English version.
Score on a questionnaire created specifically for individuals aged between 6-17 years that encompasses aspects of musical interests, musical profile, role of music and music-related activities.
The newly created questionnaire will be in an easily understandable language. The responses of implanted patients will be compared with those of their normal hearing peers.
Secondary outcomes
The impact of hearing with CI on the perception and enjoyment of music.
To study the impact of factors unrelated to CI performance (educational level, previous musical experience, listening habits, musical training and culture, or mood), on the results of the music questionnaires, the score on the Meludia music tool and the fundamental vocal parameters.
Sponsors and contacts
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Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Lead sponsor
Instituto de Salud Carlos III
Collaborator