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Предстои набиране NCT06841900

Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients

Заболявания: Cochlear Impant Children

Спонсор: University Hospital, Antwerp

Налично на: БГ
Обобщение
The aim of this study is to implement the International Classification of Functioning, disability and health (ICF) in paediatric Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss in a multicenter prospective study to evaluate audiological rehabilitation after cochlear implantation. For this, ICF qualifiers which denote the magnitude of the level of health or severity of the problem will be quantified. Outcome measures include four questionnaires and three standard audiological examinations. Subjects will be assessed up to 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor.
Кой може да участва
Inclusion Criteria: General * Children aged \< 18 years with prelingual bilateral severe-to-profound HL * Signed and dated informed consent, informed permission and/or minor's assent. * Willingness to participate in evaluations, test sessions, and medical follow-up sessions as defined in the protocol. * Physical and mental competence to participate in fitting of the device and follow-up sessions as defined in the protocol. Audiological * Completion of hearing assessment battery showing suitability of the CI candidates. * Compliance with cochlear implant candidate selection criteria of the implanting centre. * First cochlear implantation Medical * Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI). Exclusion Criteria: General * Re-implantation of the cochlear implant * No motivation to participate in the study and/or unreasonable expectations. Medical * Presence of contra-indications for surgery in general and cochlear implantation in particular. * Presence of central auditory lesions. * Any disorder that may relate to an increased risk of skin flap problems Use of one of the following electrodes for implantation * Compressed * Split * Any type of custom made electrodes
Места на провеждане 6
Австралия (1)
Fiona Stanley Fremantle Hospital Group
Perth
Белгия (1)
University Hospital Antwerp
Edegem
Германия (1)
University Clinic of Würzburg
Würzburg
Полша (1)
World Hearing Centre
Warsaw
Saudi Arabia (1)
King Abdullah Ear Specialist Center (KAESC)
Riyadh
Испания (1)
Hospital La Paz
Madrid
Технически детайли
Статус
Предстои набиране
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Здрави доброволци
Не
Начална дата
01.03.2025
Крайна дата
01.03.2027
Регистрационен номер
NCT06841900
Източник
anzctr
Запитване за медицински туризъм

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