Musical Training in Cochlear Implant Users

NCT06540677 | Not Yet Recruiting

• 1 other identifier: PI-5880
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Deafness; Perception, Bilateral

Keywords

Cochlear implant; Musical training; Auditory Perception; Speech Perception; Cognitive Function; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Score obtained to evaluate the effects of music training in speech perception

  12 weeks

• Score obtained to evaluate the effects of music training in cognitive skills

  12 weeks

• Score obtained to evaluate the effects of music training in quality of life

  12 weeks

Study Arms (2)

Musical training (MT Group)

EXPERIMENTAL

Based on the literature review, 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). In sessions 0 (at enrollement), 1, and 2, they will complete the MuRQoL or MuQPP to evaluate their exposure to music and the AQoL-8D to evaluate their quality of life. Further, they will perform the "Listen up" test, the cognition tests, and the audiological tests in quiet and in noise.

Other: Musical training

Non Musical training (NMT Group)

NO INTERVENTION

Participants won't perform musical training. In sessions 0 (at enrolment), after 4 weeks , and again after 12 additional weeks, they will complete the MuRQoL or MuQPP to evaluate their exposure to music and the AQoL-8D to evaluate their quality of life. Further, they will perform the "Listen up" test, the cognition tests, and the audiological tests in quiet and in noise.

Interventions

Musical training OTHER

Musical training with Meludia software, an online self-paced music training application

Musical training (MT Group)

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• All participants in both groups will have been implanted either unilaterally or bilaterally with CI devices from the manufacturer MED-EL (Innsbruck, Austria).

You may not qualify if:

• Participants will be excluded from the study if they have visual or motor impairments that prevent them from seeing the computer screen and pressing the correct keys, or if there is evidence of cognitive decline. Participants who have previously used Meludia software will also be excluded.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Related Publications (1)

• Calvino M, Gavilan J, Lassaletta L. Use of Meludia to evaluate the effect of music training in cochlear implant users: study protocol of a randomised controlled study. BMJ Open. 2025 Apr 25;15(4):e092207. doi: 10.1136/bmjopen-2024-092207.

  PMID: 40280615 DERIVED

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Miryam Calvino

  La Paz University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miryam Calvino, PhD

CONTACT

+34917277000; miryamcf@yahoo.com

Miryam Calvino

CONTACT

+34917277000

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share