Hearing Loss, Sensorineural, BilateralNCT04719728
Evaluate Audiological Outcome of Cochlear Implant Program in Sohag University Hospital
An observational study of Hearing Loss, Sensorineural, Bilateral, run by Sohag University.
Trial summary
Evaluation of the outcome of cochlear implantation (CI) is very important issue since adequate hearing is linked to improved communication outcomes and school performance, development of speech and language, enhances speech perception in quiet and noise and even allows CI recipients to use the telephone. Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Hearing Loss, Sensorineural, Bilateral
- What is being tested?
- Aided pure tone audiometry
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Mar 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cochlear implant recipients in Sohag University Hospital
Who may be able to join
- -
- Patients who received cochlear implant at Sohag university hospital and fulfill the following criteria:
- Age: from one year up to 60.
- Prelingual who had one year of regular speech therapy
- Postlingual patients.
Who cannot join
- none
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Audiological Outcome of Cochlear Implant Program at Sohag University Hospital
Evaluation of the outcome of cochlear implantation (CI) is very important issue since adequate hearing is linked to improved communication outcomes and school performance, development of speech and language, enhances speech perception in quiet and noise and even allows CI recipients to use the telephone.
As well as there is a growing need for a widely used set of international quality standards on minimal outcome measurements to determine outcomes in CI recipients, monitor the auditory progress of CI recipients over time and to be able to relate on important issues as the most ideal age for implantation and the cut-off audiological thresholds for CI indication.
Read more
This study will be conducted to evaluate outcome of cochlear implantation in sohag university hospital.
Aim of work:
To evaluate the outcome of cochlear implantation in Sohag university hospital.
Read the detailed description
Materials and Methods:
- It is a prospective study on cochlear implant recipients in sohag cochlear implant unite from 2014: 2020.
- Subjects: Cochlear implant recipients in sohag cochlear implant unite from 2014: 2020.
Subjects will be divided into 2 categories:
- Prelingual patients: subdivided into 3 groups
- Cochlear implant recipient with no medical or radiological issues.
- Cochlear implant recipients with medical concern or with other disabilities as syndromic patients.
- Cochlear implant recipients with radiological issues.
- Postlingual patients: subdivided into 3 groups
- Cochlear implant recipients with no medical or radiological issues.
- Cochlear implant recipients with medical concern or with other disabilities as syndromic patients.
- Cochlear implant recipients with radiological issues.
Inclusion criteria:
Patients who received cochlear implant at Sohag university hospital and fulfill the following criteria:
- Age: from one year up to 60.
- Prelingual who had one year of regular speech therapy
- Postlingual patients.
- Method:
- Background information:
- History: Age, gender, Age at which hearing loss occur, cause of hearing loss, duration of hearing loss.
- Family support.
- Expectation of patient (if post lingual patient).
- Expectation of parents.
- Hearing assessment:
- Aided Pure Tone Audiometry (PTA) level.
- Speech perception
- speech perception threshold (SRT).
- Speech perception in quiet for patients who developed language and postlingual patients using phonetically Balanced words for kinder garden ( PBKG) words, phonetically balanced words for adult (PBA), word intelligibility by picture identification (WIPI) or minimal birds.
- Speech in noise test: for patients who developed language and post lingual patients. 3- Impedance telemetry. 4- Electrically evoked action potential (ECAP). 5- Cortical evoked P1N1 potential. Informed written consent will be taken from all Participant patients or their legal guardians. This search will submit for approval from Research Ethics committee of Sohag Faculty of medicine. All investigation will be done cost free.
- Conditions
- Hearing Loss, Sensorineural, Bilateral
- Being tested
- Aided pure tone audiometry
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aided pure tone audiometryDiagnostic test
Also called Speech perception test, Speech in noise, P1N1 cortical evoked potential, Impedance telemetry
aided response, speech, evoked potential
| Study group | Role | What they receive |
|---|---|---|
| pre lingual | aided response, speech perception threshold impedance telemetry electrically evoked action potential p1n1 cortical evoked potential Receives: Diagnostic Test: Aided pure tone audiometry | |
| post lingual | aided response, speech perception threshold speech in noise impedance telemetry electrically evoked action potential p1n1 cortical evoked potential Receives: Diagnostic Test: Aided pure tone audiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing threshold for Cochlear implant users at Sohag University Hospital
Pure Tone Audiometery will be used to measure the hearing threshold in decible at each frequnecy from 250 Hz to 8000 Hz
Measured: one year postoperative
Central processing of speech for cochlear implant users at Sohag university Hospital
Auditory Evoked Potential for detection of P1 wave which generated at central auditory area, Presence of P1 wave means normal speech processing, while absence of P1 wave means abnormal speech processing
Measured: one year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, Sensorineural, BilateralStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahenda Abdelmateen Moussa, Sohag University
- Investigators
- Shahenda A Moussa, Master, Principal investigator, Sohag university, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719728
- Sponsor's protocol ID
- Soh-Med-21-01-06
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: undecided
Publications
Korver AM, Smith RJ, Van Camp G, Schleiss MR, Bitner-Glindzicz MA, Lustig LR, Usami SI, Boudewyns AN. Congenital hearing loss. Nat Rev Dis Primers. 2017 Jan 12;3:16094. doi: 10.1038/nrdp.2016.94.
PubMed 28079113
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Audiological Outcome of Cochlear Implant Program at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT04719728
- Acronym / sponsor ID
- Soh-Med-21-01-06
- Conditions
- Hearing Loss, Sensorineural, Bilateral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 22 Jan 2021 (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.
Evaluation of the outcome of cochlear implantation (CI) is very important issue since adequate hearing is linked to improved communication outcomes and school performance, development of speech and language, enhances speech perception in quiet and noise and even allows CI recipients to use the telephone.
As well as there is a growing need for a widely used set of international quality standards on minimal outcome measurements to determine outcomes in CI recipients, monitor the auditory progress of CI recipients over time and to be able to relate on important issues as the most ideal age for implantation and the cut-off audiological thresholds for CI indication.
This study will be conducted to evaluate outcome of cochlear implantation in sohag university hospital.
Aim of work:
To evaluate the outcome of cochlear implantation in Sohag university hospital.
Detailed description
Materials and Methods:
- It is a prospective study on cochlear implant recipients in sohag cochlear implant unite from 2014: 2020.
- Subjects: Cochlear implant recipients in sohag cochlear implant unite from 2014: 2020.
Subjects will be divided into 2 categories:
- Prelingual patients: subdivided into 3 groups
- Cochlear implant recipient with no medical or radiological issues.
- Cochlear implant recipients with medical concern or with other disabilities as syndromic patients.
- Cochlear implant recipients with radiological issues.
- Postlingual patients: subdivided into 3 groups
- Cochlear implant recipients with no medical or radiological issues.
- Cochlear implant recipients with medical concern or with other disabilities as syndromic patients.
- Cochlear implant recipients with radiological issues.
Inclusion criteria:
Patients who received cochlear implant at Sohag university hospital and fulfill the following criteria:
- Age: from one year up to 60.
- Prelingual who had one year of regular speech therapy
- Postlingual patients.
- Method:
- Background information:
- History: Age, gender, Age at which hearing loss occur, cause of hearing loss, duration of hearing loss.
- Family support.
- Expectation of patient (if post lingual patient).
- Expectation of parents.
- Hearing assessment:
- Aided Pure Tone Audiometry (PTA) level.
- Speech perception
- speech perception threshold (SRT).
- Speech perception in quiet for patients who developed language and postlingual patients using phonetically Balanced words for kinder garden ( PBKG) words, phonetically balanced words for adult (PBA), word intelligibility by picture identification (WIPI) or minimal birds.
- Speech in noise test: for patients who developed language and post lingual patients. 3- Impedance telemetry. 4- Electrically evoked action potential (ECAP). 5- Cortical evoked P1N1 potential. Informed written consent will be taken from all Participant patients or their legal guardians. This search will submit for approval from Research Ethics committee of Sohag Faculty of medicine. All investigation will be done cost free.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre lingual | – | Diagnostic Test: Aided pure tone audiometryaided response, speech perception threshold impedance telemetry electrically evoked action potential p1n1 cortical evoked potential |
| post lingual | – | Diagnostic Test: Aided pure tone audiometryaided response, speech perception threshold speech in noise impedance telemetry electrically evoked action potential p1n1 cortical evoked potential |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cochlear implant recipients in Sohag University Hospital
Key inclusion criteria (5 listed)
- -
- Patients who received cochlear implant at Sohag university hospital and fulfill the following criteria:
- Age: from one year up to 60.
- Prelingual who had one year of regular speech therapy
- Postlingual patients.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Aided pure tone audiometryAlso: Speech perception test, Speech in noise, P1N1 cortical evoked potential, Impedance telemetryaided response, speech, evoked potential | Diagnostic test | post lingual, pre lingual |
Primary outcome
Hearing threshold for Cochlear implant users at Sohag University Hospital
Time frame: one year postoperative
Pure Tone Audiometery will be used to measure the hearing threshold in decible at each frequnecy from 250 Hz to 8000 Hz
Central processing of speech for cochlear implant users at Sohag university Hospital
Time frame: one year postoperative
Auditory Evoked Potential for detection of P1 wave which generated at central auditory area, Presence of P1 wave means normal speech processing, while absence of P1 wave means abnormal speech processing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Background: PubMed 28079113Korver AM, Smith RJ, Van Camp G, Schleiss MR, Bitner-Glindzicz MA, Lustig LR, Usami SI, Boudewyns AN. Congenital hearing loss. Nat Rev Dis Primers. 2017 Jan 12;3:16094. doi: 10.1038/nrdp.2016.94.
- Individual participant dataSharing planned: No. undecided
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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.
Shahenda A Moussa, Master principal investigator
Sohag university, Faculty of medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Sensorineural, Bilateral, run by Sohag University.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahenda A Moussa, Master (2001014489937, shahenda.abdelmaten@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing threshold for Cochlear implant users at Sohag University Hospital (time frame: one year postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04719728, which also lists 1 linked publication.
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 22 Jan 2021.