Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05319678 |
| Other study ID # |
PI-4447 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 10, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz |
| Contact |
Luis Lassaletta |
| Phone |
+34917277262 |
| Email |
llasaletta[@]salud.madrid.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Aims: To evaluate the perception and enjoyment of music in cochlear implant (CI) users using
specific questionnaires, and comparing their results with a control group of subjects with
normal hearing (NH). To analyze the musical abilities of implantees using the musical tool
Meludia, and compare the results with the control group. To perfom a voice analysis in
implanted patients, compare it with their NH peers, and check if an association with musical
perception is observed.
Design: Cross-sectional study, both the CI recipients and NH control subjects were assessed
once.
Setting and subjects: Pre-or perilingual patients aged 6 to 17 years old, and postlingual
adults who underwent cochlear implantation from 2000 to January 2023 at La Paz University
Hospital. Control group is set up with their NH peers.
Study Variables: Socio-demographic and clinical (current age, age at implantation, sex,
educational level) variables will be collected, as well as hearing loss (aetiology, duration
of deafness), and surgical (type of implant, complete or partial insertion of the electrodes,
date of surgery) data. Data from CI fitting (number of active electrodes, type of audio
processor) and hearing outcomes with the CI will also be reviewed.
Outcome variables: Specific musical skills questionnaires for adults: Munich Music
Questionnaire (MuMu) and Music Related Quality of Life Questionnaire (MuRQoL), which will be
validated. Musical questionnaire developed specifically for subjects between 6-17 years old.
Musical tool (Meludia) to assess musical perception. Praat software for voice analysis.
Analysis of the impact of the different audiological, sociodemographic and clinical variables
on hearing outcomes, and on musical perception after cochlear implantation, and comparison
with the NH control group.
Description:
METHODOLOGY
Design Cross-sectional study in which both implanted patients and control subjects without
hearing loss were tested only once.
Scope and study subjects Prior to the inclusion of subjects in the study, the approval of the
Ethics Committee of the Hospital Universitario La Paz (HULP) will be required.
STUDY GROUP (Implanted group) Adult patients (≥18 years) with postlingual hearing loss and
children (between 6 and 17 years) with prelingual or perilingual hearing loss who have
received a CI before the age of 3 years.
Patients who have received a CI from 2000 to January 2023 will be included as potential
candidates for participation. Currently 76 subjects aged 6-17 years implanted before the age
of 3 years and 231 post-lingual adults are identified in the database, to which post-lingual
adults implanted in the next 2 years should be added, so that after one year of follow up
they can participate in the study.
Inclusion criteria:
- Minimum age of 6 years.
- Patients aged 6-17 years must have been implanted before the age of 3 years (to ensure
adequate CI performance).
- Minimum 12 months experience with the device
- Indications: unilateral (one CI), bilateral (two CIs), bimodal (one CI in one ear and a
hearing aid in the other)
- At least 80% of electrodes active at the time of assessment.
- Fluency in Spanish
- Signed and dated informed consent prior to starting any study procedure.
Exclusion criteria:
- Not meet inclusion criteria.
- Prelingual or perilingual adults.
- Disability in addition to hearing impairment (e.g., mental disability). Routine visits
in the HULP or at their CI fitting sessions will be used as an opportunity to contact
patients and propose their participation.
CONTROL GROUP The control group will be composed of subjects over 6 years of age without
hearing impairment, without a disability that prevents them from taking the tests and who
have socio-demographic characteristics similar to those of the study group. They will be
included from the ENT Department where they will have come either with another type of
medical condition other than hearing loss, or accompanying patients. Hospital La Paz staff
(or family members) who wish to carry out the tests may also be included. They must be fluent
in Spanish to ensure that they understand the study and its purpose. To confirm that the
control group does not have hearing impairment, they will undergo tonal audiometry in both
ears, whose tonal threshold should be ≤30dB in the conversational frequencies of 500, 1000
and 2000Hz.
Socio-demographic and clinical variables Study group: affiliation data (current age, age at
implantation, sex, education level), hearing loss data (aetiology, duration of hearing loss,
type and degree of hearing loss, worst ear), surgery data (type of implant and electrode
array used, complete or incomplete insertion, side implanted, date of intervention),
postoperative complications. These data will be collected from the patients' medical records.
In addition, fititing data (number of active electrodes, processor model) and audiological
tests with the CI will be collected.
Control group: age, sex, associated pathology(ies), level of education.
Outcome variables
1. Scoring of the music-related quality of life questionnaire (MuRQoL), the Munich music
questionnaire (MuMu) and the questionnaire developed for subjects aged 6-17 years (see
description).
2. Validation of the music-related quality of life questionnaire (MuRQoL) in adult
population.
3. Score obtained in the "discovery" level with the Meludia music tool (see description).
4. Parameters to assess voice quality:
Spoken voice: Vocal inability index, Maximum phonation time, Fundamental voice
frequency, Jitter, Shimmer, Harmonics to noise ratio (HNR), Smoothed cepstral peak
(CPPS) and Spectrogram according to Yanagihara's classification.
Sung voice: Pitch (relative to the note emitted by a keyboard), CPPS and Singing power
ratio (SPR).
5. Impact of demographic and audiological factors on the results of the music perception
questionnaires as well as on the results of the Meludia tool and the acoustic analysis
of the implanted patients and comparison with the normal hearing control group.
Description of the measurement instruments
1. - MuMu Questionnaire: The Munich Music Questionnaire was especially developed for the
adult CI users population with postlingual hearing loss. It includes questions that
address past and present activities related to the habit of listening to music. We will
use the abbreviated version which contains 9 questions on music listening habits in
relation to various musical styles, different instruments and participation in musical
activities at different times in the life of implanted patients. It offers many response
options, from the "yes or no" format to rating scales and multiple choice questions with
the possibility to tick as many options as necessary (e.g. "How often do you listen
and/or have you listened to music", on a scale of 0-10; "Why do you listen to music",
with the options of "for pleasure", "professional reasons", "emotional satisfaction",
"to relax"). It is translated and validated in Spanish (developed by S.J. Brockmeier and
adapted by Ana Fuster. Info:
https://www.medel.com/support/rehab/rehabilitation-downloads).
2. MuRQoL Questionnaire: The concept of music related quality of life (MuRQoL) was
initially defined as the impact of listening skills on the quality of life of implanted
patients. To work on this concept, groups of adult CI users created the questions, thus
ensuring content validity, differing from previous studies in that users were not
involved in the initial question generation process. The MuRQoL questionnaire addresses
novel aspects of musical experience, such as the ability to hear whether one is singing
at the right pitch. It uses a 5-point Likert-type scale or satisfaction scale, which
includes a range of opinions allowing for a greater degree of specificity than a yes/no
question. Five of the 18 questions included are novel among music questionnaires
designed for adult CI users, (question 4 - "can you recognise words in songs?", 6, 9, 10
and 15 - "do you listen to music while travelling, e.g. in the car?"). This is important
for assessing musical experiences that have not been measured by previous
questionnaires. On the other hand, several questions are similar to those of other
questionnaires, e.g. question 18 is also reflected in the MuMu test ("Do you sing, play
a musical instrument or whistle?"). The questionnaire consists of two parts with the
same 18 questions each, divided into musical perception and musical engagement. Part I
of the questionnaire asks about musical experiences, e.g. "Can you differentiate between
different rhythms in music? Part II asks about the importance of music listening skills,
attitudes towards music and musical activities for the implant recipient, e.g. "How
important is it for you to be able to distinguish different rhythms in music?" Dritsakis
G, van Besouw RM, Kitterick P, Verschuur CA. A Music-Related Quality of Life Measure to
Guide Music Rehabilitation for Adult Cochlear Implant Users. American journal of
audiology 2017;26:268-282.
3. Questionnaire for subjects aged 6-17 years: After reviewing the existing literature, we
did not find any questionnaire suitable both in language and in the form of scores for
subjects aged 6-17 years. Therefore, we have made a selection of questions that have
already been used by other authors and that encompass aspects of musical interests,
musical profile, role of music and music-related activities [Pacheco et al., 2020;
Vannatta-Hall, 2010; Waaramaa et al., 2018] (See Annex).Pacheco L, Miguel JHS, Gil D.
Musical stimulation proposal for hearing impaired children: case reports. CoDAS
2020;32:e20190139; Vannatta-Hall JE: Music education in early childhood teacher
education: the impact of a music methods course on pre-service teachers' perceived
confidence and competence to teach music. University of Illinois at Urbana-Champaign,
2010; Waaramaa T, Kukkonen T, Mykkänen S, Geneid A. Vocal Emotion Identification by
Children Using Cochlear Implants, Relations to Voice Quality, and Musical Interests.
Journal of speech, language, and hearing research : JSLHR 2018;61:973-985.
4. Meludia: The music tool Meludia (www.meludia.com), available in Spanish, uses
interactive music listening exercises of progressive difficulty for both children and
adults. It is based on listening and responding. Meludia poses questions using sounds
and colourful graphic designs, which after listening carefully (patients controlled
directly and those implanted through the connection cable that allows direct listening
through the audio processor) are selected with the PC mouse by clicking on the button
that best corresponds to what has just been heard. Different categories are evaluated:
Rhythm (indicate how many percussion beats are heard, from 1 to 8), Melody (indicate
whether the melody heard is ascending or descending), Density (indicate how many sounds
are heard simultaneously, one or several), Stability (indicate whether the sound heard
is chaotic or not; that is, whether it gives a feeling of stability or instability) and
Spatialisation (indicate whether the second note has a higher or lower pitch than the
first one). The tool consists of 4 modules: Discovery, Intermediate, Advanced and
Expert. In this study we will initially work with the Discovery module, which consists
of 25 exercises (5 for each of the 5 categories indicated above) (see appendix). Scores
(between 1 and 3) will be collected for each of the exercises, as well as whether or not
each category is completed. A maximum of 4 attempts will be allowed in each of the
exercises. If after the 4 attempts the subject is not able to obtain at least a score of
1, the test shall stop in that category and move on to the next category. The test shall
start with the "rhythm" category, which is considered the easiest category.
5. Acoustic analysis of the voice: the Praat programme will be used (developed by Paul
Boersma and David Weenink of the University of Amsterdam), which is the most widely used
in publications related to the subject 6 and whose values have been compared with other
programmes validated in Spanish 7.
The sound signal will be collected with a Saramonic International microphone (3.5 mm)
and a spoken voice recording will be made according to the protocol of the European
Society of Laryngology 8:
- Vowel /a/ held for at least 3 seconds.
- Phonetically balanced text ("Platero y yo" by Juan Ramón Jiménez).
- Voice recording sung with the first phrase of the popular song "Cumpleaños feliz"
prolonging the last vowel /i/ for at least 3 seconds.
The parameters to be analysed in order to evaluate the quality of the voice are the
following:
Spoken voice: Vocal incapacity index, Maximum phonation time, Fundamental frequency of
the voice, Jitter, Shimmer, Harmonics to noise ratio (HNR), Smoothed cepstral peak
(CPPS) and Spectrogram according to Yanagihara's classification.
Sung voice: Pitch (with respect to the note emitted by a keyboard), CPPS and Singing
power ratio (SPR).
6. - Description of the audiological tests: the study group will undergo tonal and speech
audiometry in free field to obtain objective values of their CI performance. This will
be carried out in a double-walled acoustically insulated booth and the subjects will be
seated 1 m away from the speakers at 0º azimuth. If a patient has better hearing in the
non-implanted ear, this ear will be masked during the test thus eliminating the
perception of the "good ear" and assessing CI performance only, and if the patient is
wearing a hearing aid it will be removed for the test. For tonal audiometry the
frequencies of 250, 500, 1000, 2000, 4000 and 6000Hz will be evaluated and for
statistical purposes the PTA4 value (average thresholds at 500,1000, 2000 and 4000Hz)
will be used. Speech perception will be evaluated with the % of disyllables both in
quiet and in noise, without lip reading, at 65dB SPL, and with a signal to noise ratio
of 10dB SPL below the signal; the recorded tracks of Cardenas and Marrero will be used.
Procedure for completion of the questionnaires and performance of the musical and voice test
*Study group: After receiving information about the study, both oral and written, and signing
the informed consent form, patients will fill in the MuMu and MuRQoL questionnaires (adults)
and the questionnaire developed for subjects aged 6-17 years with the help of a member of the
research team (children will also be assisted by their parents or guardians).
The musical test with the Meludia tool, which we estimate to last approximately 1 hour, will
be carried out after completing the questionnaires, or else they will be scheduled for
another day within the following 30 days. The audio input of the CI processor will be
connected to the audio output of the laptop computer, in order to completely isolate the
signal from external noise. Once all the Meludia exercises have been completed, the voice
will be analysed with the Praat programme.
*Control group: normal hearing patients will receive oral and written information about the
study and after signing the informed consent they will fill in the MuRQoL questionnaire if
they are over 18 years old or the one developed for subjects between 6-17 years old. They
will then be assessed with the Meludia tool and subsequently with the Praat programme.
Both the questionnaires and the test with the Meludia tool will be administered to each
patient individually in a quiet environment. If the youngest children do not manage to
complete all the exercises in a single session, they will be scheduled for the following
days, always within the next 30 days, taking advantage of one of their routine check-ups.
Given the current pandemic situation due to SARS-COV2, in order to minimise the time it takes
for both the study group and the controls to visit the hospital, a self-completing version of
the questionnaires would be created so that they can be filled in online. Assessment with
Meludia can also be performed remotely via Webex, Zoom or Teams; in this case, implanted
patients would have the cable connecting the processor(s) to the audio output of the PC
delivered to their homes. In the same way as the voice analysis, which, after sending the
corresponding microphone to the subjects, could be carried out remotely.
Since the study tests (Meludia music tool, questionnaires and voice analysis) will only be
tested once on each subject, there is no need to follow up the groups. While all implantees
have an annual check-up throughout their lifetime, no changes in performance are expected
unless there is an accident or device failure. Therefore, the results of the study are not
expected to change over time. The control group, on the other hand, is made up of normal
hearing subjects, with the ability to perform the tests correctly, i.e. without a disability
that prevents them from doing so (e.g. mental impairment) and this ability should not vary
substantially over time. As there is no follow-up on the subjects (the "measures" are only
performed once in time) there will be no losses in the study.
Translation of the MuRQoL questionnaire Initially, the questionnaire will be translated from
English to Spanish by a suitably qualified person. This will be followed by translation from
Spanish to English (back-translation) by another qualified person from outside the clinical
study. This will ensure that the Spanish version faithfully reproduces the original English
version.
Statistical analysis Quantitative variables will be expressed as mean, standard deviation and
range, and qualitative variables as absolute frequencies and percentages. For the analysis of
the results of the MuMu music perception test before and after the CI, the Wilcoxon test for
paired data will be used. To assess the influence of socio-demographic and clinical variables
on the results of music perception after the hearing implant, comparisons of means between
groups will be made using non-parametric methods (Kruskall-Wallis for more than two groups
and Mann-Whitney for two groups) or parametric methods (ANOVA for more than two groups and
Student's t-test for two groups), depending on the sample sizes, the homogeneity of the data
and the adjustment to the normality of the distribution. Spearman's correlation coefficient
will be used to analyse the relationship between verbal discrimination after CI and the
measurement of music perception and enjoyment. All analyses will be performed at a two-tailed
p<0.05 level of statistical significance. The statistical package SPSS v.24 will be used for
the proposed analyses.
For the validation of the MuRQoL questionnaire, the method of Rust & Golombok, 2000 will be
used. Reliability and validity will be taken into account. Reliability is assessed through
consistency (assessed through Cronbach's alpha coefficient), temporal stability (test-retest
reliability, calculated with the intraclass correlation coefficient) and inter-observer
agreement (analysed through the percentage of agreement and the Kappa index), and validity
through content validity (qualitative assessments to be made by expert researchers),
construct validity (factor analysis and multitrait-multimethod matrix) and criterion validity
(relation of each subject's score to a Gold Standard, in this case to the scores obtained in
the original item [Dritsakis et al. , 2017]).
Dritsakis G, van Besouw RM, Kitterick P, Verschuur CA. A Music-Related Quality of Life
Measure to Guide Music Rehabilitation for Adult Cochlear Implant Users. American journal of
audiology 2017;26:268-282.
Regarding sample size determination, this is the first study with the Meludia music tool in a
child population, so it is not possible to know with certainty the sample size needed to find
significant differences between the study group and the control group. But based on a recent
study published by our group where there is an implanted population and their control peers
("matched" by gender, age, educational level...), the number of patients in the study group
and 24 controls was set at 24 (Mertens G., et al. 2020. Cognitive Improvement After Cochlear
Implantation in Older Adults With Severe or Profound Hearing Impairment: A Prospective,
Longitudinal, Controlled, Multicenter Study. Ear and hearing), with 75% power to detect a
difference of 14 standard deviations (= Cohen's d; Claes, A. J., et al. 2018. Cognitive
performance of severely hearing-impaired older adults before and after cochlear implantation:
Preliminary results of a prospective, longitudinal cohort study using the RBANS-H. Otol
Neurotol, 39, e765-e773).
Limitations of the study The retrospective design for the selection of patients is not an
obstacle since the data collection, the completion of the questionnaires and the musical test
with Meludia are evaluated prospectively, allowing us to control possible biases related to
this type of design, such as the loss of information.
One of the possible limitations we might encounter is the refusal of some patients to stay
longer than necessary in a hospital room. This could be solved by offering them the
possibility of doing the exercises online, with an internet connection at home, and we could
guide them through the exercises.
