ClinicalTrials.gov
ClinicalTrials.gov Menu

Cochlear Implants Registry in Thailand Project (CIRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02830659
Recruitment Status : Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by (Responsible Party):
Kwanchanok Yimtae, M.D., 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.

Condition or disease
Cochlear Implantation

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Only
Official Title: Cochlear Implants Registry in Thailand Project
Study Start Date : July 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Quality of life [ Time Frame: 5 years ]
    The quality of life will be assessed by interviewing questionnaires using HUI-3.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who underwent surgery for cochlear implant
Criteria

Inclusion Criteria:

  • Patients who underwent surgery with cochlear implant

Exclusion Criteria:

  • Patients who reject to participate with this project

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830659


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

Responsible Party: Kwanchanok Yimtae, M.D., Director of Neuro-otology unit, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02830659     History of Changes
Other Study ID Numbers: HE591146
HSRI. 59-031 ( Other Grant/Funding Number: Health System Research Institution )
CERT004/59BRm ( Other Identifier: Central Research Ethics Committee )
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016