Analysis of Musical and Voice Skills in Children and Adult Cochlear Implant Users

NCT05319678 | Recruiting

• 1 other identifier: PI-4447
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cochlear Implant; Music; Voice

Outcome Measures

Primary Outcomes (6)

• 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).

  3 years

• 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.

  3 years

• 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.

  3 years

• 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.

  3 years

• Score obtained in the "discovery" level with the Meludia music tool

  To analyse the musical abilities of implanted patients over 6 years of age using the musical tool "Meludia" with its 5 musical categories: rhythm, melody, density, stability and spatialisation, and to compare their results with those obtained in subjects with normal hearing.

  3 years

• Change in voice quality of CI users compared with their normal hearing control peers.

  Voice analysis: In implanted patients over 6 years, study various parameters to evaluate voice quality, e.g. vocal incapacity index, maximum phonation time, fundamental voice frequency, pitch... and compare them with the results in their normal hearing control peers. Parameters to assess voice quality: Spoken voice: Vocal inability index, Maximum phonation time, Fundamental voice frequency, Jitter, Shimmer, Harmonics to noise ratio (HNR), Smoothed cepstral peak (CPPS) and Spectrogram according to Yanagihara's classification. Sung voice: Pitch (relative to the note emitted by a keyboard), CPPS and Singing power ratio (SPR).

  3 years

Secondary Outcomes (1)

• The impact of hearing with CI on the perception and enjoyment of music.

  3 years

Study Arms (2)

Cochlear implant users

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

Other: evaluation with Meludia music software

Normal hearing subjects

Control group is set up with the normal hearing peers of cochlear implant users

Other: evaluation with Meludia music software

Interventions

evaluation with Meludia music software OTHER

Measurement 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

Also known as: voice analysis with Praat software

Cochlear implant users; Normal hearing subjects

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• 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)
• At least 80% of electrodes active at the time of assessment.
• Fluency in Spanish
• Signed and dated informed consent prior to starting any study procedure.

You may not qualify if:

• Prelingual or perilingual adults.
• Disability in addition to hearing impairment (e.g., mental disability).

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitario de La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Related Publications (1)

• Lassaletta L, Calvino M, Sanchez-Cuadrado I, Munoz E, Gavilan J. Can anatomy-based fitting improve musical perception in adult cochlear implant users? Braz J Otorhinolaryngol. 2025 Mar-Apr;91(2):101533. doi: 10.1016/j.bjorl.2024.101533. Epub 2024 Nov 19.

  PMID: 39566293 DERIVED

Study Officials

• Luis Lassaletta

  Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Lassaletta

CONTACT

+34917277262; llasaletta@salud.madrid.org

Miryam Calvino

CONTACT

miryamcf@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigador. PhD

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 8, 2022
• Study Start: February 10, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-02

Locations

ES (1)