Clinical trial NCT05196022: Hear Again, Work Again
Official title: Impact of Treating Unilateral and Bilateral Severe-to-profound Sensorineural Hearing Loss on Productivity and Social Wellbeing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss, Sensorineural, Severe
Hearing Loss, Sensorineural, Bilateral
Hearing Loss, Unilateral
Hearing Loss, Sensorineural, Profound
Cochlear Implants
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Cochlear
First posted: 2022-01-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators aim to include patients with severe-to-profound hearing loss that would qualify for reimbursement of a cochlear implant (CI) (G1 + G2). A proportion of these patients will not opt for CI (e.g. because of optimal hearing aid fitting) and will be included as G1. Patients receiving CI are G2. In addition, the investigators aim to include 50 single-sided deafness in the acute setting (G3) and 50 single-sided deaf patients (G4).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in sick leave after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in self-reported productivity after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
Secondary outcomes:
measure: Change in health state based on the EQ-5D-5L after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in health state based on the Health Utilities questionnaire (HUI-3) after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Subjective data logging CI
timeFrame: 3 months
measure: Objective data logging CI
timeFrame: 3 months
measure: Subjective data logging CI
timeFrame: 6 months
measure: Objective data logging CI
timeFrame: 6 months
measure: Subjective data logging CI
timeFrame: 12 months
measure: Objective data logging CI
timeFrame: 12 months
measure: Change in treatment-specific health-related Quality of Life based on the Nijmegen Cochlear Implant Questionnaire (NCIQ) after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in treatment-specific health-related Quality of Life based on the Amsterdam Inventory for Auditory Disability and Handicap (AIADH) after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in general sense of preceived self-efficacy after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in medical cost after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in anxiety and depression after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in need for recovery after work after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in socio-professional reintegration after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in cognition based on the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals (RBANS-H) after 3, 6 and 12 months
timeFrame: Baseline; 12 months
measure: Change in visuospatial short-memory after 3, 6 and 12 months
timeFrame: Baseline; 12 months
measure: Change in hearing thresholds after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in speech perception in quiet after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
measure: Change in speech perception in noise after 3, 6 and 12 months
timeFrame: Baseline; 3 months; 6 months; 12 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
state: Antwerpen
Study officials:
affiliation: University Hospital, Antwerp
name: Vincent Van Rompaey
role: STUDY_DIRECTOR
References: