Paraverbal Components of Language and Cochlear Implant (NCT05950412) | Clinical Trial Compass
UnknownNot Applicable
Paraverbal Components of Language and Cochlear Implant
Italy37 participantsStarted 2023-06-01
Plain-language summary
The investigators evaluated patients older than 6 years old, with severe hearing loss, cochlear implant wearers, able to perform a series of tests (TUISE, the pitch discrimination test, the melody discrimination test, VAS) to assess the skills of perceiving spectral components of music and understanding emotional states of language investigating the relationship between musical ability, pitch discrimination and paraverbal language comprehension.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients with severe-profound sensorineural hearing loss undergoing cochlear implantation at Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy;
* Intracochlear implant placement in soft surgery technique, by mastoidectomy and posterior tympanotomy and insertion of the electrode array through the round window
* age \>6 years
* patients without associated disabilities, with good auditory verbal perceptual skills and adequate language skills
* the ability to understand and perform the tests administered
Exclusion Criteria:
* pulsating tinnitus
* congenital malformation of the auditory system
* history of vestibular schwannoma, active middle ear disease and complete ossification of the cochlea.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pitch discrimination test
Timeframe: 6 months after cochlear implantation
2
Melody discrimination test
Timeframe: 6 months after cochlear implantation
3
TUISE (Auditory Test of Identifying Emotional States)