Musical Training in Cochlear Implant Users
NCT Number: NCT06540677
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Deafness; Perception, Bilateral
Interventions: OTHER: Musical training
Sponsor: Hospital Universitario La Paz
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-30

Summary:
With this protocol we want to investigate the degree to which the use of Meludia training (the online self-paced music training application) can improve music perception, music enjoyment, and speech understanding in pediatric and postlingually deafened adult CI users. The study also aims to assess the participants' changes in cognitive skills (attention and memory) and quality of life.

Participant recruitment Group A: New CI users All postlingually deafened patients older than 6 years who undergo cochlear implantation at the La Paz Hospital in Madrid (Spain) between September 2024 and September 2027 will be invited to participate in the study.

Group B: Experienced CI users CI users older than 6 years old with at least 12 months of stable fitting will be recruited from the CI program at the La Paz Hospital between September 2024 and September 2027. Within this group this group, it will be required that pediatric CI have been implanted before the age of 3 years.

Both in the Group A and in the Group B, participants at the time of enrolment will be randomly divided 1:1 into two groups, with subjects being instructed to practice with Meludia music training application (intervention group: MT group) and participants in the non-MT group non receiving music training (NMT group).

We will establish 20 minute sessions three times per week over a period of 4 weeks for participants in the MT group. After this period, all the participants will be evaluated (session 1). An additional training period of 12 weeks, also with 20-min sessions three times per week, will then be conducted in the MT group, followed by another evaluation (session 2).

The ongoing protocol for music training cannot replace conventional tools in the rehabilitation of CI users. However, after scientific-based improvement of music practice protocols (easily implementable, low-priced, and with little probability of adverse effects) as an auditory practice rehabilitation along with the conventional methods, music training may provide an important tool for the aural rehabilitation plan

Primary Outcome Measures: Score obtained to evaluate the effects of music training in music perception, "Listen Up" music exercises will be used to evaluate music perception, 12 weeks|Score obtained to evaluate the effects of music training in music enjoyment, 1. MuRQoL (Music Related Quality of Life) questionnaire will be used to quantify both the frequency and importance of music in adults CI users. Score: 0-5, higher results means better performance
2. The Music Questionnaire for Pediatric Population will be used to quantify music enjoyment in children with CI. Score: 0-10, higher results means better performance, 12 weeks
Secondary Outcome Measures: Score obtained to evaluate the effects of music training in speech perception, 1. Disyllables in silence will be used to evaluate speech perception in CI users (0-100%).
2. Matrix test will be used to evaluate speech perception in noise in adults with CI.

Higher results means better performance, 12 weeks|Score obtained to evaluate the effects of music training in cognitive skills, 1. Mini Mental State Examination will be used to assess cognitive skills in adult CI users.
2. The Performance intelligence quotient and the Wechsler intelligence scale for children will be used to assess cognitive skills in children with CI Higher results means worse cognitive skills, 12 weeks|Score obtained to evaluate the effects of music training in quality of life, 1.The AQoL-8D (Assessment of Quality of Life-8 dimentions) questionnaire will be used to assess. individual's quality of life in adult CI users.

Score: 1.00 (full health) to 0.00 (death-equivalent health states) to -0.04 (health states worse than death), 12 weeks