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CompletedNCT05942261MRSIUpdated Nov 27, 2024

Rehabilitation Methods of Children With Cochlear Implant

An observational study in Deafness Neurosensory, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
30
Ages
1 Year to 10 Years
Sex
All
01

Study summary

The goal of this observational study is to describe the type of the rehabilitation method for italian children with cochlear implant . The main questions are:

What is the most used rehabilitation methods in implanted children? Which is the prevalence of each method related to the clinical features of the patients?

Read the detailed description

The cochlear implant represents the gold standard in the treatment of children with bilateral severe-profound deafness. However, the current Italian and international guidelines do not address the issue of rehabilitation and how the different rehabilitation methods should be applied in relation to the different clinical pictures. The aim of this study is therefore to describe which methods are used today in the rehabilitation of deaf children with cochlear implants followed at the Phoniatrics and Speech Therapy service of the A. Gemelli Polyclinic Foundation. The creation of a questionnaire directed to the speech therapist who treats the specific patient is available in order to collect data concerning the characteristics of the setting and the rehabilitation method in relation to the most applied methodologies, i.e. Auditory-verbal therapy, oral-cognitive therapy, bimodal method and the Drežančić method.

Inclusion Criteria:

  • Children diagnosed with severe-profound hearing loss and cochlear implant carriers followed at the Fondazione Policlinico universitario a. Gemelli in the last 10 years;
  • Age >12 months and \<10 years

Exclusion Criteria:

  • Children diagnosed with mild to moderate hearing loss without a cochlear implant;
  • Age \<12 months and >10 years

Outcomes measures

  • Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant
  • Describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients.

Endpoints:

-% distribution of the 4 rehabilitation methods: cognitive oralism, verb-tonal, Auditory-Verbal therapy and bimodal

  • % distribution of the 4 rehabilitation methods: cognitive oralism, verbal-tonal, Auditory-Verbal Therapy and bimodal in relation to the clinical characteristics of the patients.
02

Conditions studied

  • Deafness Neurosensory

Keywords

  • cochlear implant
  • deafness
  • rehabilitation
03

In context

Deafness

609 studies on the registry are indexed under Deafness; 111 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 168 observational studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children diagnosed with severe-profound hearing loss and cochlear implant carriers followed at the Fondazione Policlinico Universitario A. Gemelli, Rome

Inclusion criteria

  • Patients diagnosed with severe to profound hearing loss who underwent cochlear implant placement surgery in the last 10 years;
  • Age >12 months and \<10 years

Exclusion criteria

Exclusion Criteria:

  • Patients diagnosed with mild to moderate hearing loss without a cochlear implant
  • Age \<12 months and >10 years
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • OtherSurvey to collect data

    The study is a survey aimed to collect data about rehabilitation methods

06

What researchers measure

Primary outcomes

  1. Methods

    Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant.

    Time frame: 3 months

Secondary outcomes

  1. Prevalence

    Describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients.

    Time frame: 2 months

07

Study locations

1 site
  • Fondazione Policlinico Universitario A. Gemelli
    Roma, RM 00168, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05942261
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
mari Giorgia (Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Jul 12, 2023
Start date
May 9, 2023
Primary completion
Sep 30, 2023
Completion
Dec 30, 2023
Last update
Nov 27, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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