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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04602780
Other study ID # 20/23/300
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 4, 2019
Est. completion date July 13, 2020

Study information

Verified date October 2020
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Work Related Questionnaire (WORQ) is a 59-item questionnaire of which each item represents an International Classification of Functioning and disability category. The WORQ was modified and reduced to include only questions relevant to Cochlear Implant (CI) users. In this analysis, a multicentre retrospective review of the revised WORQ in CI users was performed, with the revised WORQ as part of the questionnaires used in the regular clinical follow-up of CI users. Experienced CI users' responses on the questions will be evaluated to define the qualifiers for the revised WORQ.


Recruitment information / eligibility

Status Completed
Enrollment 177
Est. completion date July 13, 2020
Est. primary completion date July 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults over the age of 18 years - Adults must wear a MED-EL cochlear implant - Adults may have the following hearing indications and device fitting: - Unilateral cochlear implant with severe-to-profound hearing loss - Bilateral cochlear implant with severe-to-profound hearing loss - Single sided deafness (SSD) where the poorer ear PTA =70 dB HL and the better ear PTA =30 dB HL with an interaural threshold gap of =40 dB HL. - Asymmetrical hearing loss using a cochlear implant in the poorer ear and a hearing aid in the better ear (also known as bimodal fitting). The poorer ear PTA =70 dB HL and the better ear PTA >30 dB HL and =55 dB HL with an interaural threshold gap of =15 dB HL. - Adults should have a minimum of one year's device experience Exclusion Criteria No extra exclusion criteria

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Australia Fiona Stanley Fremantle Hospital Group Perth
Belgium University Hospital Antwerp Edegem
Germany University Clinic of Würzburg Würzburg
Poland World Hearing Centre Kajetany
Spain Hospital La Paz Madrid

Sponsors (5)

Lead Sponsor Collaborator
University Hospital, Antwerp Fiona Stanley Hospital, Hospital Universitario La Paz, World Hearing Centre, Wuerzburg University Hospital

Countries where clinical trial is conducted

Australia,  Belgium,  Germany,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Completion of the WORQ questionnaire Part 1: Work situation and educational background of participants
School education
Remunerative employment
Part 2: Daily life functioning of participants
Emotional functions
Vestibular functions
Carrying out daily routine
Stress
Conversation
Communication devices and techniques
Tinnitus and dizziness
Community life
Family relationships
Part I addresses demographics and relevant background information. In Part 2, participants have to rate to what extent they had problems with a certain task or activity in the last week based on a numerical scale ranging from 0 (no problem) to 10 (complete problem).
Each individual WORQ item is linked to an ICF qualifier, which is a numerical code that specifies the extent or magnitude of functioning or disability in that ICF category or the extent to which a contextual factor is a facilitator or barrier.
One test interval, at least one year after Cochlear Implantation
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