Cochlear Implants Registry in Thailand Project (CIRT)

July 9, 2016 updated by: Kwanchanok Yimtae, M.D., Khon Kaen University
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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Bangkok, Thailand, 10220
        • King Bhumibol Adulyadej Hospital
      • Bangkok, Thailand, 10400
        • Department of Otolaryngology Phramongkutklao College of Medicine
      • Bangkok, Thailand, 26120
        • Department of Otolaryngology, Srinakharinwirot University
      • Chiang Mai, Thailand, 50200
        • Department of Otolaryngology, Faculty of Medicine, Chiang Mai University
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital
      • Songkhla, Thailand, 90110
        • Songkhlanagarind Hospital
      • Trang, Thailand, 92000
        • Trang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient who underwent surgery for cochlear implant

Description

Inclusion Criteria:

  • Patients who underwent surgery with cochlear implant

Exclusion Criteria:

  • Patients who reject to participate with this project

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAP 1
Time Frame: 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.
1 year
Quality of life
Time Frame: 5 years
The quality of life will be assessed by interviewing questionnaires using HUI-3.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Collaborators

Ministry of Health, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

July 2, 2016

First Submitted That Met QC Criteria

July 9, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 9, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • HE591146
  • HSRI. 59-031 (Other Grant/Funding Number: Health System Research Institution)
  • CERT004/59BRm (Other Identifier: Central Research Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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