Cochlear Implants Registry in Thailand Project

• Conditions: Cochlear Implantation

• Registration Number: NCT02830659
• Lead Sponsor: Khon Kaen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-02
• Study First Submitted QC: 2016-07-09
• Last Update Submitted: 2016-07-09
• Study First Posted: 2016-07-13
• Last Update Posted: 2016-07-13
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Patients who underwent surgery with cochlear implant

Exclusion Criteria

• Patients who reject to participate with this project

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aids Threshold 1	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.

Secondary Outcome Measures

Name	Time	Method
CAP 1	1 year	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.
Quality of life	5 years	The quality of life will be assessed by interviewing questionnaires using HUI-3.

Trial Locations

Locations (11)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand

Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand

Trang Hospital; 🇹🇭 Trang, Thailand

Department of Otolaryngology Phramongkutklao College of Medicine; 🇹🇭 Bangkok, Thailand

Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Department of Otolaryngology, Srinakharinwirot University; 🇹🇭 Bangkok, Thailand

Songkhlanagarind Hospital; 🇹🇭 Songkhla, Thailand

King Bhumibol Adulyadej Hospital; 🇹🇭 Bangkok, Thailand

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand

Department of Otolaryngology, Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand