Analysis of Musical and Voice Skills in Children and Adult Cochlear Implant Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in voice quality of CI users compared with their normal hearing control peers.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Not meet inclusion criteria.
- •Prelingual or perilingual adults.
- •Disability in addition to hearing impairment (e.g., mental disability).
结局指标
主要结局
Change in voice quality of CI users compared with their normal hearing control peers.
时间窗: 3 years
Voice analysis: In implanted patients over 6 years, study various parameters to evaluate voice quality, e.g. vocal incapacity index, maximum phonation time, fundamental voice frequency, pitch... and compare them with the results in their normal hearing control peers. 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).
Scoring on a specific musical questionnaire for adults: MuMu
时间窗: 3 years
Change in the musical experience and degree of enjoyment of music before and after CI in adult (≥18 years) post-lingual patients with the Munich Music Questionnaire (MuMu).
Score on a questionnaire created specifically for individuals aged between 6-17 years that encompasses aspects of musical interests, musical profile, role of music and music-related activities.
时间窗: 3 years
The newly created questionnaire will be in an easily understandable language. The responses of implanted patients will be compared with those of their normal hearing peers.
Scoring on a specific musical questionnaire for adults: MuRQoL
时间窗: 3 years
Change in music perception with the Music Related Quality of Life (MuRQoL) questionnaire in postlingually hearing adults (≥18 years) with CI and compare it with the results in subjects with normal hearing.
Translation and validation the MuRQoL questionnaire in Spanish.
时间窗: 3 years
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.
Score obtained in the "discovery" level with the Meludia music tool
时间窗: 3 years
To analyse the musical abilities of implanted patients over 6 years of age using the musical tool "Meludia" with its 5 musical categories: rhythm, melody, density, stability and spatialisation, and to compare their results with those obtained in subjects with normal hearing.
次要结局
- The impact of hearing with CI on the perception and enjoyment of music.(3 years)
研究者
Luis Lassaletta
Principal Investigador. PhD
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz