Hear Again, Work Again

  • STATUS
    Recruiting
  • End date
    Jan 25, 2024
  • participants needed
    200
  • sponsor
    University Hospital, Antwerp
Updated on 25 March 2022

Summary

Project synopsis:

This prospective cohort study investigates impact of (1) hearing loss and (2) cochlear implantation on cost and health state on one hand, and employment, productivity and social wellbeing on the other hand in a professionally active group using validated questionnaires.

Participants

The investigators aim to include 100 professional active adults between 18 and 65 years old. All participants have a bilateral severe-to-profound sensorineural or mixed hearing loss. Due to several reasons such as an optimal hearing aid fitting, the presence of a residual hearing or physical contra-indications, half of these participants will not be implanted with CI. Additionally, 100 participants with a single-sides deafness (SSD) in the acute or chronic setting (SDD present for at least three months) will be included.

Study design

Study measures:

All audiological tests and patient-reported outcome measures will be included in this test protocol and repeated throughout the follow-up visits depending on aided or unaided setting. The cognitive evaluation will be executed during the first and last test moment.

The investigators anticipate that the protocol will take 1 hour per follow-up in the hospital (audiological testing and to go over the questionnaires), plus an extra hour at home to fill out the questionnaires. For the cognitive tests, an extra hour in the hospital will be scheduled.

Hypothesis

As a primary endpoint, the investigators anticipate demonstrating that severe-to-profound hearing loss has a significant impact on sick leave and self-reported productivity.

Health state will also be analyzed as a secondary endpoint because the investigators anticipate only marginal improvement (if any) on these instruments due to the lack of sensitivity and responsiveness, even in this population. The investigators will also determine the rate of usage and non-usage at this long-term follow-up to demonstrate the utility of cochlear implants.

Statistical analysis

IBM SPSS Statistics (IBM; Armonk, NY) will be used for the statistical analyses. The participants' hearing profiles will be summarized using descriptive statistics (median, and range). In view of the sample size, non-parametric tests and linear mixed models (to describe evolution in time and difference between groups) will be used. Quantitative data will be presented as median and range (minimum and maximum). Descriptives will be used to summarize the outcomes of the subjective data logging. For the speech perception in noise results, a Wilcoxon signed-rank test will be used. In addition, to correct for the multiple speech in noise test configurations, Holm's correction will be applied. The level of significance will be set at p.0.05.

Data storage

REDCap (Research Electronic Data Capture) is a secure, web-based application designed exclusively to support data capture for research studies. REDCap provides an interface for data entry (with data validation) and audit trails for tracking data manipulation and export procedures. Data will be pseudomized before storage in REDCap.

Details
Condition Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Bilateral, Hearing Loss, Unilateral, Hearing Loss, Sensorineural, Profound, Cochlear Implants
Treatment Cochlear Implant
Clinical Study IdentifierNCT05196022
SponsorUniversity Hospital, Antwerp
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age between 18 and 65 years
Unilateral or bilateral severe-to-profound sensorineural or mixed hearing loss
Ability to understand and speak Dutch
Resident in Flanders

Exclusion Criteria

Already implanted with a cochlear implant
Conductive hearing loss
Congenital hearing loss
Inability to complete audiological or cognitive evaluation
Inability to complete questionnaires
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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