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

• Cochlear Implantation

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