NCT05942261

Brief 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

July 4, 2023

Last Update Submit

November 25, 2024

Conditions

Deafness Neurosensory

Keywords

cochlear implantdeafnessrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Methods

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

    3 months

Secondary Outcomes (1)

  • Prevalence

    2 months

Interventions

Survey to collect dataOTHER

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

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Hearing Loss, SensorineuralDeafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 12, 2023

Study Start

May 9, 2023

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations

IT(1)