NCT02830659

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

5 years

First QC Date

July 2, 2016

Last Update Submit

July 9, 2016

Conditions

Cochlear Implantation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • CAP 1

    1 year

  • Quality of life

    5 years

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who underwent surgery for cochlear implant

You may qualify if:

  • Patients who underwent surgery with cochlear implant

You may not qualify if:

  • Patients who reject to participate with this project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

King Bhumibol Adulyadej Hospital

Bangkok, Bangkok, 10220, Thailand

Location

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

Department of Otolaryngology Phramongkutklao College of Medicine

Bangkok, Bangkok, 10400, Thailand

Location

Rajavithi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Ramathibodi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

Department of Otolaryngology, Srinakharinwirot University

Bangkok, Bangkok, 26120, Thailand

Location

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Songkhlanagarind Hospital

Songkhla, Changwat Songkhla, 90110, Thailand

Location

Trang Hospital

Trang, Changwat Trang, 92000, Thailand

Location

Department of Otolaryngology, Faculty of Medicine, Chiang Mai University

Chiang Mai, Chiang Mai, 50200, Thailand

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neuro-otology unit

Study Record Dates

First Submitted

July 2, 2016

First Posted

July 13, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

July 13, 2016

Record last verified: 2016-07

Locations

TH(11)