Deafness NeurosensoryMRSINCT05942261
Rehabilitation Methods of Children With Cochlear Implant
An observational study of Deafness Neurosensory, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Deafness Neurosensory
- What is being tested?
- Survey to collect data
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 9 May 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with severe-profound hearing loss and cochlear implant carriers followed at the Fondazione Policlinico Universitario A. Gemelli, Rome
Who may be able to join
- 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
Who cannot join
- Patients diagnosed with mild to moderate hearing loss without a cochlear implant
- Age <12 months and >10 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation Methods of Children With Cochlear Implant: a Cross-sectional Survey
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.
- Conditions
- Deafness Neurosensory
- Being tested
- Survey to collect data
- Keywords
- cochlear implant, deafness, rehabilitation
- Medical subject headings
- Hearing Loss, Sensorineural, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey to collect dataOther
The study is a survey aimed to collect data about rehabilitation methods
What is being measured
The primary outcome is the main question the study is designed to answer.
Methods
Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant.
Measured: 3 months
Secondary outcomes (1)
Prevalence
Describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start9 May 2023
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deafness NeurosensoryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mari Giorgia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942261
- Sponsor's protocol ID
- 5685
- Acronym
- MRSI
- Status last verified
- Nov 2024
- First submitted
- 4 Jul 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Methods of Children With Cochlear Implant: a Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT05942261
- Acronym / sponsor ID
- MRSI / 5685
- Conditions
- Deafness Neurosensory
- Keywords
- cochlear implant, deafness, rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with severe-profound hearing loss and cochlear implant carriers followed at the Fondazione Policlinico Universitario A. Gemelli, Rome
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients diagnosed with mild to moderate hearing loss without a cochlear implant
- Age <12 months and >10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey to collect dataThe study is a survey aimed to collect data about rehabilitation methods | Other | – |
Primary outcome
Methods
Time frame: 3 months
Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant.
1 secondary outcome
Prevalence
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deafness Neurosensory, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methods (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.