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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
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