Hear Again, Work Again

NCT05196022 | Recruiting

• 1 other identifier: 2021-0306
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Sensorineural, Severe; Hearing Loss, Sensorineural, Bilateral; Hearing Loss, Unilateral; Hearing Loss, Sensorineural, Profound; Cochlear Implants

Outcome Measures

Primary Outcomes (2)

• Change in sick leave after 3, 6 and 12 months

  Work Productivity and Activity Impairment Questionnaire - Specific Health Problem. To determine the impact of hearing loss on work productivity the investigators will use "hearing loss" as the specific health problem to develop the WPAI: Hearing as a responsive tool to evaluate work productivity in a hearing impaired population. This questionnaire consists of six items. Four different outcomes will be calculated: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. A higher percentage (minimum=0%; maximum= 100%) on each subscale indicates a greater impact on work productivity.

  Baseline; 3 months; 6 months; 12 months

• Change in self-reported productivity after 3, 6 and 12 months

  The Work Limitations Questionnaire (WLQ) measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ items ask respondents to rate their level of difficulty or ability to perform specific job demands. The WLQ's 25 items are aggregated into four scales: time management scale, physical demands scale, cognitive job tasks and output demands scale. Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. Additionally, using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss where a high score indicates that the participant is limited for a great amount of time.

  Baseline; 3 months; 6 months; 12 months

Secondary Outcomes (20)

• Change in health state based on the EQ-5D-5L after 3, 6 and 12 months

  Baseline; 3 months; 6 months; 12 months

• Change in health state based on the Health Utilities questionnaire (HUI-3) after 3, 6 and 12 months

  Baseline; 3 months; 6 months; 12 months

• Subjective data logging CI

  3 months

• Objective data logging CI

  3 months

• Subjective data logging CI

  6 months

Study Arms (4)

G1

Patients with bilateral severe to profound hearing loss that would qualify for reimbursement of en cochlear implant but will not opt for a cochlear implant.

G2

Patients with bilateral severe to profound hearing loss that would qualify for reimbursement of en cochlear implant and receive a cochlear implant

Other: Cochlear implant

G3

Patients with a single-sided deafness in an acute setting

G4

Patients with a single-sided deafness in a chronic setting

Interventions

Cochlear implant OTHER

G2 will receive a cochlear implant during the study

G2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Cochlear: collaborator

Study Sites (1)

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Related Publications (1)

• Philips C, Jacquemin L, Lammers MJ, Wouters K, Moyaert J, Vanderveken O, Van Rompaey V. Impact of hearing impairment and cochlear implantation on productivity and social well-being in a professionally active but severely hearing-impaired group: protocol of the 'Hear again, work again' longitudinal prospective cohort study. BMJ Open. 2023 Mar 8;13(3):e064514. doi: 10.1136/bmjopen-2022-064514.

  PMID: 36889821 DERIVED

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Unilateral

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Vincent Van Rompaey

  University Hospital, Antwerp

  STUDY DIRECTOR

Central Study Contacts

Cato Philips

CONTACT

038212435; Cato.Philips@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 19, 2022
• Study Start: December 10, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)