Cochlear ImplantationCIRTNCT02830659
Cochlear Implants Registry in Thailand Project
An observational study of Cochlear Implantation, run by Khon Kaen University at 11 sites in Thailand.
Trial summary
The purpose of this study is to determine the outcome of cochlear implant including post operative hearing ability, developing of language, complication from cochlear implant, quality of life, and success factor of cochlear implant. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cochlear Implantation
- How many people
- 1,500 participants
- Where
- 11 sitesThailand
- Study dates
- Jul 2016to Jul 2021
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient who underwent surgery for cochlear implant
Who may be able to join
- Patients who underwent surgery with cochlear implant
Who cannot join
- Patients who reject to participate with this project
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Thailand11 sites
King Bhumibol Adulyadej Hospital
Bangkok, Bangkok, 10220
King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, 10330
Department of Otolaryngology Phramongkutklao College of Medicine
Bangkok, Bangkok, 10400
Rajavithi Hospital
Bangkok, Bangkok, 10400
Ramathibodi Hospital
Bangkok, Bangkok, 10400
Siriraj Hospital
Bangkok, Bangkok, 10700
Department of Otolaryngology, Srinakharinwirot University
Bangkok, Bangkok, 26120
Department of Otolaryngology, Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, 50200
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, 40002
Songkhlanagarind Hospital
Songkhla, Changwat Songkhla, 90110
Trang Hospital
Trang, Changwat Trang, 92000
About this study
The purpose of this study is to determine the outcome of cochlear implant including post operative hearing ability, developing of language, complication from cochlear implant, quality of life, and success factor of cochlear implant.
- Conditions
- Cochlear Implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Aids Threshold 1
The pure tone air-conduction threshold at 0.25, 0.5, 1, 2, 3, 4, 6, 8 kilohertz, measuring in the sound-proof room using the standard audiometry while patient is using cochlear implants.
Measured: 1 year
Secondary outcomes (2)
CAP 1
Categories of Auditory Performance (CAP) is an index consisting of eight performance categories, relating to auditory perception. It is arranged in a hierarchy of skills that increase in difficulty for example from the ability to perceive environmental sounds right up to using the telephone. It is widely used in the range of current research on children with cochlear implants and is an easy to use tool for monitoring progress.
Measured: 1 year
Quality of life
The quality of life will be assessed by interviewing questionnaires using HUI-3.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantationStudies of the same condition, open and under way.
- 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
- Case only
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Responsible party
- Principal investigator, Kwanchanok Yimtae, M.D., Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830659
- Sponsor's protocol ID
- HE591146
- Other IDs
- HSRI. 59-031, CERT004/59BRm
- Acronym
- CIRT
- Status last verified
- Jul 2016
- First submitted
- 2 Jul 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cochlear Implants Registry in Thailand Project
- ClinicalTrials.gov ID
- NCT02830659
- Acronym / sponsor ID
- CIRT / HE591146
- Conditions
- Cochlear Implantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Study start
- Jul 2016
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 13 Jul 2016 (estimated)
- 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 purpose of this study is to determine the outcome of cochlear implant including post operative hearing ability, developing of language, complication from cochlear implant, quality of life, and success factor of cochlear implant.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who underwent surgery for cochlear implant
Key inclusion criteria (1 listed)
- Patients who underwent surgery with cochlear implant
Key exclusion criteria (1 listed)
- Patients who reject to participate with this project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aids Threshold 1
Time frame: 1 year
The pure tone air-conduction threshold at 0.25, 0.5, 1, 2, 3, 4, 6, 8 kilohertz, measuring in the sound-proof room using the standard audiometry while patient is using cochlear implants.
2 secondary outcomes
CAP 1
Time frame: 1 year
Quality of life
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implantation, run by Khon Kaen University at 11 sites in Thailand.
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 1 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Thailand. 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?
Results are not available in the source record.
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?
Aids Threshold 1 (time frame: 1 year). 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 13 Jul 2016; AzTrials last refreshed its copy on 1 Nov 2026.