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NCT02830659 Clinical Trial

Cochlear Implants Registry in Thailand Project

Cochlear Implantation Clinical Trial

— CIRT  

Official title:
Cochlear Implants Registry in Thailand Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02830659
Other study ID # HE591146
Secondary ID HSRI. 59-031CERT
Status Active, not recruiting
Phase N/A
First received July 2, 2016
Last updated July 9, 2016
Start date July 2016
Est. completion date July 2021

Study information
Verified date July 2016
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority Thailand: Khon Kaen University Ethics Committee for Human Research
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1500
Est. completion date July 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender Both
Age group 1 Year and older
Eligibility Inclusion Criteria:

- Patients who underwent surgery with cochlear implant

Exclusion Criteria:

- Patients who reject to participate with this project

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

Locations
Country Name City State
Thailand Department of Otolaryngology Phramongkutklao College of Medicine Bangkok
Thailand Department of Otolaryngology, Srinakharinwirot University Bangkok
Thailand King Bhumibol Adulyadej Hospital Bangkok
Thailand King Chulalongkorn Memorial Hospital Bangkok
Thailand Rajavithi Hospital Bangkok
Thailand Ramathibodi Hospital Bangkok
Thailand Siriraj Hospital Bangkok
Thailand Department of Otolaryngology, Faculty of Medicine, Chiang Mai University Chiang Mai
Thailand Srinagarind Hospital Khon Kaen
Thailand Songkhlanagarind Hospital Songkhla
Thailand Trang Hospital Trang

Sponsors (2)
Lead Sponsor Collaborator
Khon Kaen University Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 year No
Secondary 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. 1 year No
Secondary Quality of life The quality of life will be assessed by interviewing questionnaires using HUI-3. 5 years No
See also
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Recruiting NCT04906135 - Auditory Neural Function in Implanted Patients With Usher Syndrome N/A
Recruiting NCT06040892 - Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children N/A
Completed NCT02902497 - Impact of the Surgical Experience on Cochleostomy Location: A Comparative Temporal Bone Study Between Endaural and Posterior Tympanotomy Approaches for Cochlear Implantation N/A
Not yet recruiting NCT06375278 - Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation N/A
Completed NCT03256097 - Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System N/A
Not yet recruiting NCT05917496 - Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
Completed NCT04192968 - Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results
Recruiting NCT05547113 - Vestibular Function in Cochlear Implant Patients
Not yet recruiting NCT05122364 - Telerehabilitation & Telecoaching of Parents of Cochlear Implanted Children at Sohag University Hospital N/A
Completed NCT03958006 - Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma N/A
Completed NCT03950375 - Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation