Deafness; Perception, BilateralNCT06540677
Musical Training in Cochlear Implant Users
A study testing Musical training in people with Deafness; Perception, Bilateral, run by Hospital Universitario La Paz.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Deafness; Perception, Bilateral
- What is being tested?
- Musical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Miryam Calvino contact
About this study
Official title: Use of Meludia to Evaluate the Benefits of Music Training in Cochlear Implant Users: a Randomized
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.
Read more
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
- Being tested
- Musical training
- Keywords
- Cochlear implant, Musical training, Auditory Perception, Speech Perception, Cognitive Function, Quality of life
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical trainingOther
Musical training with Meludia software, an online self-paced music training application
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score obtained to evaluate the effects of music training in music perception
"Listen Up" music exercises will be used to evaluate music perception
Measured: 12 weeks
Score obtained to evaluate the effects of music training in music enjoyment
- 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
Measured: 12 weeks
Secondary outcomes (3)
Score obtained to evaluate the effects of music training in speech perception
- 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
Measured: 12 weeks
Score obtained to evaluate the effects of music training in cognitive skills
- 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
Measured: 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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deafness; Perception, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miryam Calvino, Hospital Universitario La Paz
- Investigators
- Miryam Calvino, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540677
- Sponsor's protocol ID
- PI-5880
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40280615
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Meludia to Evaluate the Benefits of Music Training in Cochlear Implant Users: a Randomized
- ClinicalTrials.gov ID
- NCT06540677
- Acronym / sponsor ID
- PI-5880
- Conditions
- Deafness; Perception, Bilateral
- Keywords
- Cochlear implant, Musical training, Auditory Perception, Speech Perception, Cognitive Function, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Musical training (MT Group) | Experimental | Other: Musical trainingBased 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. |
| 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musical trainingMusical training with Meludia software, an online self-paced music training application | Other | Musical training (MT Group) |
Primary outcome
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
Score obtained to evaluate the effects of music training in music enjoyment
Time frame: 12 weeks
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
3 secondary outcomes
Score obtained to evaluate the effects of music training in speech perception
Time frame: 12 weeks
Score obtained to evaluate the effects of music training in cognitive skills
Time frame: 12 weeks
Score obtained to evaluate the effects of music training in quality of life
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 40280615Calvino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miryam Calvino contact
Miryam Calvino principal investigator
La Paz University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Musical training in people with Deafness; Perception, Bilateral, run by Hospital Universitario La Paz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miryam Calvino, PhD (+34917277000, miryamcf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score obtained to evaluate the effects of music training in music perception (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06540677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.