Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06540677

Musical Training in Cochlear Implant Users

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Musical training

Other

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

Primary outcomes

  1. Score obtained to evaluate the effects of music training in music perception

    Time frame: 12 weeks

    "Listen Up" music exercises will be used to evaluate music perception

  2. Score obtained to evaluate the effects of music training in music enjoyment

    Time frame: 12 weeks

    • 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
    • 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

Secondary outcomes

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

    Time frame: 12 weeks

    • Disyllables in silence will be used to evaluate speech perception in CI users (0-100%).
    • Matrix test will be used to evaluate speech perception in noise in adults with CI.

    Higher results means better performance

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

    Time frame: 12 weeks

    • Mini Mental State Examination will be used to assess cognitive skills in adult CI users.
    • 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

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

    Time frame: 12 weeks

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Miryam Calvino

CONTACT

+34917277000

Miryam Calvino, PhD

CONTACT

[email protected]

+34917277000

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study title

Use of Meludia to Evaluate the Benefits of Music Training in Cochlear Implant Users: a Randomized

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.