Abstract
Introduction
Although most cochlear implant (CI) users achieve good speech understanding in quiet without visual cues, they may have limited speech understanding in noise and often have poor music perception. The present study was designed to investigate the degree to which the use of Meludia training can improve music perception, music enjoyment and speech understanding in paediatric 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.
Methods and analysis
This randomised controlled trial will randomise new CI users and experienced CI users older than 6 years who meet the inclusion criteria in a 1:1 ratio to either a musical training (MT) group or a non-MT (NMT) group. The NMT group will receive standard care that does not include MT. Participants in the MT group will practise with Meludia software for 4 weeks and later for 12 additional weeks. Outcomes will include scores in: ‘Listening Up’ exercises, the -Music-Related Quality of Life questionnaire, the Music Questionnaire for Paediatric Population, Disyllables in silence, Matrix test, Mini Mental State Examination, Performance IQ and the Wechsler intelligence scale for children and the Assessment of Quality of Life—8 Dimensions questionnaire. The NMT group will receive standard care that does not include MT.
Ethics and dissemination
On 16 October 2023, the study protocol was approved by the La Paz Hospital in Madrid (Spain). The findings of this study will be published in peer-reviewed publications and presented at appropriate conferences.
Trial registration number
Keywords: Quality of Life, MEDICAL EDUCATION & TRAINING, Audiology, Cognition
STRENGTHS AND LIMITATIONS OF THIS STUDY.
Meludia software can be used by cochlear implant (CI) users of all ages at home, on their preferred times and days. The connection and use time will be monitored through their login information.
The inclusion of patients from a single hospital may limit the generalisability of the study results.
The intervention period may not be long enough to test improvements in CI users.
Introduction
Cochlear implants (CIs) are surgically implanted devices that can restore auditory perception to individuals with hearing loss. Although most CI users achieve good speech understanding in quiet without visual cues, they may have limited speech understanding in noise and often have poor music perception.1 This poor perception of music may be unsatisfactory to the user and can often be a disappointing aspect of their auditory experience. As reported by Limb and Roy,2 this is due to a combination of technological (eg, limitations in pitch representation of the CI device itself), biological (eg, peripheral and central auditory system deficits including brain plasticity) and acoustic limitations faced by the user. Therefore, CI users do not accurately perceive certain acoustic characteristics (pitch, timbre, rhythm and melody)3 that are essential for experiencing music, in particular fundamental frequency.4
Some authors have highlighted the importance of enjoyment and qualitative appraisal as an outcome measure to evaluate music appreciation.5 The fact of no correlation between perceptual outcomes and appreciation6 revealed the need to evaluate appreciation separately. Prelingually deafened children with a CI do not have any prejudices of how music should sound like compared with postlingually deafened CI users. Fact that could provide some benefits for perceptual and appreciation outcomes in the paediatric population.7
In addition, factors such as age, longer durations of auditory deprivation, life experiences and cognitive skills that support musical skills may influence musical enjoyment in CI users.8,10 Despite these limitations, most CI users are increasingly optimistic that the benefits of cochlear implantation can go beyond spoken communication and provide additional benefits to music participation and enjoyment.11
Over the last years, various studies have explored different approaches to improve music perception in CI users. These studies aimed at enhancing speech processing strategies,12 modifying the temporal envelope of pulse amplitudes (which is lower than in listeners with normal hearing),13 revising the compression of the electric dynamic range14 and reducing the mismatch between the frequency band allocations of the audio processor and the corresponding locations of the array electrodes with respect to their tonotopic positions within the cochlea.15 However, despite these efforts to enhance CI signal processing, substantial benefits to music perception have not been reported as yet.
Another avenue to improve music perception and enjoyment in CI users may be through musical training (MT). A number of studies have reported a variety of different implementations of music training methods for CI users.16,19 For example, Smith et al19 used the HearTunes (Rehab) software that encompassed a comprehensive approach with challenging tasks for CI users; others used either audiobook listening18 or in-person group activities17 as a control group; Firestone et al16 even used a home-based training software with emphasis on melody to analyse later electroencephalographic recordings.
One of these methods is the online self-paced music training application Meludia20 (Meludia SAS, Paris, France). In a randomised controlled trial, Jiam et al demonstrated improvements in pitch discrimination and in timbre identification in CI users with this application.18 Boyer et al also observed that the application has a gentle learning curve for CI users, where the easiest exercises are accessible to users regardless of their age, indication, duration of CI use or their musical background.21 In a prior study, the authors of the present study demonstrated that this application can be used for music training in younger CI users, with participants as young as 6 years being able to complete exercises.22 Recently, Meludia was used as a music rehabilitation app in a non-randomised clinical trial with adult CI users receiving 16 Meludia sessions at home.23
There has been little prior work investigating the minimal training period needed to observe improvements in musical skills. According to a recent meta-analysis, reported MT periods have ranged from 1 month to 36 months.24 Long training periods may improve training effects but may also lead to a higher level of participant drop-out. Conversely, shorter training intervals may improve compliance and lower the drop-out rate but may also reduce training effects.18 Furthermore, spacing out training sessions over time is widely accepted not only in psychology,25 but also among CI recipients.5 It is known that in-person music training programmes may limit patient participation due to the time required to travel to the centre, travel ability and financial resources.26
Alternatively, Lo et al,7 for example, explained that technical issues and challenges were found when using apps for online training, such as the need for a proper online connection with no retarded loading times. However, users generally expressed high enjoyment with the use of apps, also influenced by the tactile elements involved.
Besides, it is known that music and speech have several acoustic similarities and share neural pathways.27 This means the areas of the brain that handle speech perception also play a role in music processing.28 Thus, there is a natural connection between speech perception and music perception skills. Enhancement of speech in noise after a music-based intervention has been demonstrated both in children with severe hearing loss7 and CI users29 after a music-based intervention. In a systematic review30 after the evaluation of papers for the quality of their research design and the suitability of their analysis techniques, the author concluded that the majority of the evaluated studies were statistically underpowered or had poor methodologies and no relationship between music training and speech perception in hearing-impaired listeners could be established. Similarly, in a very recent study, Frosolini et al23 reported no significant differences in speech perception in noise between adult CI users who were performing music-specific rehabilitation and the control group.
The aim of the study outlined in this protocol is to investigate the degree to which the use of Meludia training can improve (1) music perception, (2) music enjoyment and (3) speech understanding in paediatric and postlingually deafened adult CI users. The study also aims to assess the participants’ changes in (4) cognitive skills (attention and memory) and (5) quality of life.
Methods and analysis
Patient and public involvement
Patients were not involved in the development of the protocol.
Participant recruitment and inclusion/exclusion criteria
Group A: new CI users
All postlingually deafened patients older than 6 years (no upper age limit) who undergo cochlear implantation at the La Paz Hospital in Madrid (Spain) between March 2025 and December 2027 will be invited to participate in the study.
Group B: experienced CI users
CI users older than 6 years old (no upper age limit) with at least 12 months of stable fitting will be recruited from the CI programme at the La Paz Hospital between March 2025 and December 2027. Within this group, it will be required that paediatric 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).
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.
Informed consent and study ethics
All study procedures will be explained to all participants prior to the beginning of the study. Participation will be entirely voluntary, and this will be made clear to each potential participant. Each participant (or their guardians in case of paediatric CI users from 6 to 17 years) will be asked to sign a written informed consent form, which will be a requirement for inclusion in the study.
In accordance with the Declaration of Helsinki, participants are free to discontinue their participation at any time and for any reason, without prejudicing their basic right to receive the best treatment available for their condition.
Study design
Both in Group A and in Group B, participants at the time of enrolment will be randomly divided 1:1 into two groups in parallel, with subjects being instructed to practice with the Meludia music training application (intervention group: MT group) and participants in the non-MT group not receiving music training (NMT group).
The Meludia training programme is structured into four main modules based on their difficulty level: Discovery, Intermediate, Advanced and Expert. Each main module includes eight groups of exercises, referred to as ‘stars’. A star consists of different exercises, which are based on five dimensions of musical perception (Melody, Harmony, Spatialisation, Rhythm and Form). One exercise can belong to one or more of these dimensions. Each exercise has five levels of difficulty (which is distinct from the difficulty level of the main module outlined above). As an example, participants will have to identify if the pitch is higher or lower, if the melody is ascending or descending. An example of the star interface is shown in figure 1.
Figure 1. Illustration of the interface of the Meludia platform. The Discovery main module is shown with its five dimensions (Density representing ‘Form’, Rhythm, Spatialisation, Stable/unstable representing ‘Harmony’, Melody) and a description thereof. Modified from https://www.meludia.com .20.
Based on the literature review, we will establish 20-min 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).
All participants in the MT group will receive an on-site demonstration of the programme during one of their routine hospital visits and instructions on how to practise during the training sessions. Moreover, participants will receive written instructions on how to proceed when they use Meludia at home on their own computer/laptop/tablet. They will listen to the exercises and play them in free field from the device speaker. They will be invited to:
Start with the Discovery module with the easiest exercises of the first star and generally follow the outlined structure of Meludia.
Practice for 20 min three times per week.
Return to the previous level of difficulty when performance is unsuccessful with higher-level exercises.
Explore and practice exercises of all five different musical dimensions.
Move on to a different exercise when getting stuck at a certain level of difficulty.
Go back to previous levels if you get stuck on an exercise repeatedly over several sessions and try to reach three points for each level of that exercise.
Participants of group A will also attend speech language rehabilitation sessions.
After 20 min of practice, participants will stop and continue on the next scheduled day from where they left off, or they may choose to start a new session. Participants will be free to browse through the different Meludia exercises. Bilaterally implanted participants practise with both implants on simultaneously.
Enrolment and baseline
Participants will be screened at enrolment via the inclusion and exclusion criteria. Information will be collected from participants who meet the inclusion criteria. This will include demographic characteristics such as age, sex, education and general clinical characteristics (eg, aetiology of hearing loss, duration of hearing loss, use of hearing aids).
All included participants will perform the ‘Listen Up’ music exercises (see below for details) and perform the disyllables speech perception test in silence. Adult participants will complete the Music-Related Quality of Life (MuRQoL) Questionnaire, the Assessment of Quality of Life—8 Dimensions (AQoL-8D), the Mini Mental State Examination (MMSE) and the Spanish Matrix test. Paediatric participants will complete the Music Questionnaire for Pediatric Population (MuQPP) and perform the forward digit span test and the performance IQ (PIQ) test.
Randomisation
Participants were allocated to groups at the baseline visit after signing the informed consent. Allocation to the MT group or NMT group was done by the principal investigator (MC) using minimisation software.31 Minimisation seeks to achieve a balance across the arms of a trial on one or more predefined patient characteristics.32 The minimisation balanced the following factors:
Age
Gender
Date of surgery in group B of experienced users
Type of audio processor
Description of measuring instruments
‘Listen Up’ music exercises were developed by MED-EL to train and assess music perception in CI users. These exercises cover the following areas: dynamics, pitch, tone length, timbre, melody, rhythm and instrument recognition. Different musical pieces are played, and the participant has to, for example, recognise the pitch or identify the instrument. The music perception assessment consists of 7 items; 1–6 points can be achieved per item.9 This test will be done using the direct audio input cable to ensure that hearing is tested via CI alone. Bilaterally implanted participants will be tested with both implants simultaneously.
Music enjoyment questionnaires (see online supplemental material):
MuRQoL questionnaire: The MuRQoL uses a 5-point Likert-type scale (1: never; 2: rarely; 3: occasionally; 4: frequently; 5: always). It consists of two parts with the same 18 questions each. Part I of the questionnaire asks about musical experiences, for example, ‘Can you recognize the words in songs?’. Part II asks about the importance of music listening skills, attitudes towards music and musical activities of the CI user, for example, ‘How important is it for you to be able to recognize the words in songs?’.33 The Spanish version of this questionnaire was recently validated by our team.34
MuQPP22: The MuQPP consists of questions that have previously been used by other authors in the paediatric population35,37 to assess musical interests, frequency of listening to music, the role of music in daily life and music-related activities. This questionnaire has yet to be validated, so the results should be interpreted with this in mind.
Speech tests
Disyllables in silence and the Spanish Matrix Tests (for adults only): The disyllabic words used will be phonetically balanced words from the everyday vocabulary developed by Cárdenas and Marrero.38 The test material will be presented at 65 dB SPL (Sound Pressure Level) by a recorded female voice. If a participant has better hearing in the non-implanted ear, this ear will be masked during testing. The Spanish Matrix Test39 is an adaptive test that measures the speech reception threshold (SRT) by using speech-noise set at 55 dB and varying the speech signal. The SRT is defined as the signal-to-noise ratio at which 50% speech recognition is achieved. It follows the method of the German Oldenburg sentence test,40 using sentences with a fixed syntactical structure that are semantically unpredictable. This test will be performed using a two-channel Madsen Astera² audiometer (Otometrics, Taastrup, Denmark) in an acoustically treated room, with signal and noise presented via the same channel (0°).
Cognition tests
MMSE: It comprises 11 questions that measure six areas of cognitive function: orientation, visuospatial abilities, attention/concentration, recall (short-term memory), language skills and ability to understand and follow instructions. Its administration only takes 5–10 min, so it is useful to be used repeatedly and routinely. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. Our study will be focused on the domains of attention and short-term memory. This test will be used for adult participants (≥18 years).
Forward Digit Span test and PIQ: The ITPA (Illinois test of psycholinguistic abilities) forward digit span subtest will be used using raw scores in the analyses. PIQ will be measured with the block design subtest of the WISC-V (Wechsler intelligence scale for children, fifth edition: Wechsler, 2015).41 This questionnaire is easy to apply and the material is appealing to children. The evaluation is simple and it is adapted to the Spanish population.
Quality of life assessment
AQoL-8D42: The AQoL-8D will be used to assess an individual’s quality of life across eight dimensions: independent living, happiness, mental health, coping, relationships, self-worth, pain and senses. It offers a holistic view with scores ranging from 0 to 1, with 1 representing the best quality of life.43
Participants follow-up
The participants’ schedule is shown in figure 2.
Figure 2. Flow chart of the study design. AQoL-8D, Assessment of Quality of Life—8 Dimensions; MT, musical training; MuQPP, Music Questionnaire for Pediatric Population; MuRQoL, Music-Related Quality of Life; NMT, non-musical training.
In session 0, participants will sign the informed consent form and complete a demographic questionnaire. In sessions 0, 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.
All tests except the ‘Listen Up’ and the speech tests will be carried out in the best hearing conditions; that is, bilaterally or bimodally.
To ensure that participants follow the study design and practice with the Meludia software for the established period, we will monitor the time they are logged into Meludia. If a participant does not meet the established criteria, we will encourage them to continue by pointing out the benefits that their participation in the study entails. If they remain reluctant, they will be excluded from the study.
Outcome measures
For the primary and secondary outcomes, see table 1.
Table 1. Primary and secondary outcomes.
| Outcome measures | |
|---|---|
| Primary outcomes | |
| Assessment of the effects of music training in music perception | 1. ‘Listen Up’ music exercises will be used to evaluate music perception. |
| Assessment of the effects of music training in music enjoyment | 1. MuRQoL questionnaire will be used to quantify both the frequency and importance of music in adults CI users.2. The Music Questionnaire for Pediatric Population will be used to quantify music enjoyment in children with CI. |
| Secondary outcomes | |
| Assessment of the effects of music training in speech perception | 1. Disyllables in silence will be used to evaluate speech perception in CI users.2. Matrix test will be used to evaluate speech perception in noise in adults with CI. |
| Assessment of 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 IQ and the Wechsler Intelligence Scale for Children will be used to assess cognitive skills in children with CI. |
| Assessment of the effects of music training on quality of life | 1. The AQoL-8D questionnaire will be used to assess individual’s quality of life in adult CI users. |
AQoL-8D, Assessment of Quality of Life—8 Dimensions; CI, cochlear implant; MuRQoL, Music-Related Quality of Life.
Quality control
To ensure the accuracy of the experiments, the investigators will regularly review study documents, informed consent forms, case report forms and data records.
Equipment
The equipment needed for this study will be an audiometer, and a computer or laptop placed in a quiet room to run the ‘Listen Up’ test.
Data collection
The principal investigator and the co-investigators of the study (members of the Department of Otorhinolaryngology, La Paz University Hospital) will collect and evaluate data from patients at recruitment and during and after the training period.
Sample size
Sample size calculation is usually based on the primary study outcome. In this study, one of these outcomes is to investigate the speech understanding improvement after Meludia training in CI users. So, based on previous studies,44 the percentage of correctly repeated disyllables shifts from 20% to 70% in adults CI users after implantation. According to http://www.imim.cat/ofertadeserveis/software-public/granmo/, with a unilateral p=0.05 and a β risk=0.2, and a 10% withdrawal rate, the minimum total sample size was calculated to be 21 participants; that is, 21 prelingually deafened children and 21 postlingually deafened adults as we will need to stratify the sample into two separate data sets to be able to draw significant conclusions.
Early withdrawal, suspension/early termination of the study
Participants will be discontinued from the study if they:
Do not meet the inclusion criteria or do meet the exclusion criteria.
Have health issues (eg, subject’s death).
Have moved away.
Do not comply with the clinical investigation plan (eg, they do not attend the visits on schedule; do not communicate relevant medical issues to the investigator).
Withdraw from the study voluntarily.
Statistical analysis
Demographic characteristics and outcome measures will be shown as absolute (n) and relative (%) frequencies and, if appropriate, as mean plus SD (±SD) and range.
Normally distributed continuous variables will be compared by t-tests and non-normally distributed continuous variables by Mann-Whitney rank-sum tests. Categorical variables will be compared by χ2 tests.
Pearson’s correlation coefficient will be calculated to assess the relationship between the mean score of the different categories of Listen Up tests, the corresponding subscales of MuRQoL and paediatric questionnaire scores, speech tests and cognition test scores.
The paediatric and adult populations will be treated independently.
Missing data will be treated as missing values. All statistical analyses will be performed by SPSS V.24.0 software (IBM, Armonk, New York, USA), with p≤0.05 considered statistically significant. All statistical tests will be two-tailed.
,
Discussion
This study will be a continuation of the recent research published by our team.22 We demonstrated that Meludia can be used as a training method for CI users of all ages (from 6 years).
A recent meta-analysis17 highlighted that CI users benefit from music training, as the improvement in music performance of CI users after music training mirrors the progress observed in normal-hearing subjects with music practice. The authors also emphasised that the age at which musical skills are acquired has a ‘sensitive window’, in the same way that speech perception has a ‘critical period’45; that is, the period when musical skills and perception quickly progress. They suggested that this sensitive window may occur before the age of 15 years. However, this does not mean that musical skills cannot improve after this age; they can still increase, but not as rapidly as within this sensitive window.24
Apart from age, other factors are known to significantly impact the outcomes to be achieved. Some studies have established that musical skills, critical listening, one’s expectations46 and the ability to focus and maintain attention during the rehabilitation period19 may help improve music enjoyment. Therefore, we consider it vitally important to assess these aspects with a questionnaire.
Conversely, some studies have observed that music training has a positive effect on some psychosocial outcomes47 and can induce similar emotions in CI users as it does in normal-hearing individuals.48 These facts could be linked to the positive effect of music-based interventions on the different cognitive subdomains.49 It is well known that the number of people with dementia has sharply increased in recent years.50 As musical skills are reported to be preserved in people with dementia,49 music-based interventions could be considered a valuable non-pharmacological intervention strategy. A systematic review and meta-analysis49 concluded that music therapy improved cognitive function (orientation and language activities), as evaluated by MMSE score.
Correspondingly, the similarities between the syntactic model of language and music, and the similarities at the acoustic level, have emphasised the theories about the effect of music on speech comprehension and language abilities.51
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.24
The major strength of the current trial is that the Meludia software can be used by CI users of all ages at home, on their preferred times and days. It is easy and intuitive with more than 600 different exercises to practice. The connection and use time will be monitored through their login information.
However, this study is still subject to some disadvantages. Its single-centre nature may limit the generalisability of the results. Additionally, the intervention period may not be long enough to test improvements in CI users. Moreover, due to the nature of the study (a two-arm design), we will not be able to differentiate the effects of the intervention itself rather than general training effects.
Trial status
The first participant will be enrolled by March 2025 and the study is expected to end in March 2028. NCT06540677.
Supplementary material
Acknowledgements
The authors would like to thank Ursula Hauer for her medical writing assistance on a version of this manuscript and Johanna Boyer for her help with the Meludia platform’s use and her invaluable musical expertise.
Footnotes
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Prepub: Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-092207).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Ethics approval: This study is being conducted in compliance with procedures approved by the La Paz Hospital Ethics Committee (approval number: PI-5880) and was registered at ClinicalTrials.gov (identifier NCT06540677).
The findings of this study will be published in peer-reviewed publications and presented at appropriate conferences.
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