Calvino Miryam, Gavilán Javier, Lassaletta Luis
Department of Otorhinolaryngology, La Paz University Hospital, Madrid, Spain
IdiPAZ Research Institute, Madrid, Spain.
BMJ Open. 2025 Apr 25;15(4):e092207. doi: 10.1136/bmjopen-2024-092207.
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.
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.
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.
NCT06540677.
尽管大多数人工耳蜗（CI）使用者在无视觉线索的安静环境中能获得良好的言语理解能力，但他们在噪声环境中的言语理解能力可能有限，且音乐感知能力往往较差。本研究旨在调查使用Meludia训练对儿童及语后聋成人CI使用者的音乐感知、音乐享受和言语理解能力的改善程度。该研究还旨在评估参与者认知技能（注意力和记忆力）和生活质量的变化。
本随机对照试验将按1:1的比例将符合纳入标准的6岁以上新CI使用者和有经验的CI使用者随机分为音乐训练（MT）组或非音乐训练（NMT）组。NMT组将接受不包括MT的标准护理。MT组的参与者将使用Meludia软件练习4周，之后再额外练习12周。结果将包括以下各项的得分：“听力提升”练习、音乐相关生活质量问卷、儿童音乐问卷、安静环境下的双音节词、矩阵测试、简易精神状态检查表、操作智商以及儿童韦氏智力量表和生活质量8维度评估问卷。NMT组将接受不包括MT的标准护理。
2023年10月16日，该研究方案经马德里（西班牙）拉巴斯医院批准。本研究结果将发表在同行评审的出版物上，并在适当的会议上展示。
NCT06540677。
