Cochlear Hearing LossNCT07068373
Development of Evidence-based Therapeutic Guidelines for Early SLA in Urdu-speaking Children With Cochlear Implants
An observational study of Cochlear Hearing Loss, run by Superior University at 1 site in Pakistan.
Trial summary
Firstly global and regional literature on speech therapy after cochlear implantation focusing on Urdu-speaking populations and culturally relevant factors will be systematically reviewed. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Cochlear Hearing Loss
- What is being tested?
- Mixed method (Exploratory Sequential)
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Apr 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Early Speech and Language acquisition of Urdu speaking children after cochlear implant
Who may be able to join
- Speech language Pathologists/ therapist with minimum 5 years of experience working with cochlear implant
- Parents of children with cochlear implant age 2 and above
Who cannot join
- Parents whose children has just cochlear implant and they have no experience of speech and language development after cochlear implant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Evidence Based Therapeutic Guidelines for Early Speech and Language Acquisition in Urdu Speaking Children With Cochlear Implant
Firstly global and regional literature on speech therapy after cochlear implantation focusing on Urdu-speaking populations and culturally relevant factors will be systematically reviewed.
Read the detailed description
Then needs Assessment will be done to understand the challenges, needs, and gaps in therapeutic practices specific to Urdu-speaking children through focus groups to gather insights into current practices and barriers. After that objective data will be collected to identify trends and outcomes in speech and language development post-implantation, measure baseline skills, and progress over time, and factors influencing outcomes i.e. age of implantation, therapy frequency. In final stage, culturally relevant and evidence-based therapeutic guidelines will be formulated.
- Conditions
- Cochlear Hearing Loss
- Being tested
- Mixed method (Exploratory Sequential)
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed method (Exploratory Sequential)Diagnostic test
4-6 Expert SLPs working with Cochlear Implant, A cohort of 100 Urdu speaking children who received cochlear implants
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert scale
A Likert scale is a psychometric scale commonly used in questionnaires to measure respondents' attitudes and opinions. It typically presents a statement and asks respondents to indicate their level of agreement or disagreement using a range of ordered response options. These options are usually assigned numerical values for scoring purposes. Scoring is designed based on such categories as "Strongly Disagree," "Disagree," "Neither Agree nor Disagree," "Agree," and "Strongly Agree." (0-5) for each question, the higher the score indicates the worse condition
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start17 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Hearing LossStudies of the same condition, open and under way.
- More trials run by Superior 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068373
- Sponsor's protocol ID
- PhDRSW/Batch-Fall23/2225
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Evidence Based Therapeutic Guidelines for Early Speech and Language Acquisition in Urdu Speaking Children With Cochlear Implant
- ClinicalTrials.gov ID
- NCT07068373
- Acronym / sponsor ID
- PhDRSW/Batch-Fall23/2225
- Conditions
- Cochlear Hearing Loss
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Jul 2025 (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.
Firstly global and regional literature on speech therapy after cochlear implantation focusing on Urdu-speaking populations and culturally relevant factors will be systematically reviewed.
Detailed description
Then needs Assessment will be done to understand the challenges, needs, and gaps in therapeutic practices specific to Urdu-speaking children through focus groups to gather insights into current practices and barriers. After that objective data will be collected to identify trends and outcomes in speech and language development post-implantation, measure baseline skills, and progress over time, and factors influencing outcomes i.e. age of implantation, therapy frequency. In final stage, culturally relevant and evidence-based therapeutic guidelines will be formulated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Early Speech and Language acquisition of Urdu speaking children after cochlear implant
Key inclusion criteria (2 listed)
- Speech language Pathologists/ therapist with minimum 5 years of experience working with cochlear implant
- Parents of children with cochlear implant age 2 and above
Key exclusion criteria (1 listed)
- Parents whose children has just cochlear implant and they have no experience of speech and language development after cochlear implant
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 |
|---|---|---|
| Mixed method (Exploratory Sequential)4-6 Expert SLPs working with Cochlear Implant, A cohort of 100 Urdu speaking children who received cochlear implants | Diagnostic test | – |
Primary outcome
Likert scale
Time frame: 18 Months
A Likert scale is a psychometric scale commonly used in questionnaires to measure respondents' attitudes and opinions. It typically presents a statement and asks respondents to indicate their level of agreement or disagreement using a range of ordered response options. These options are usually assigned numerical values for scoring purposes. Scoring is designed based on such categories as "Strongly Disagree," "Disagree," "Neither Agree nor Disagree," "Agree," and "Strongly Agree." (0-5) for each question, the higher the score indicates the worse condition
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
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Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
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Mi2000 TICI Follow-up
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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 Cochlear Hearing Loss, run by Superior University at 1 site in Pakistan.
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 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Likert scale (time frame: 18 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 16 Jul 2025.