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Hearing Loss, SensorineuralSMILENCT05525221

Societal Merit of Intervention on Hearing Loss Evaluation

An observational study of Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by Radboud University Medical Center at 5 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this study is to determine the (long term) effect of intervention with a CI in adult participants with progressive postlingual moderate/severe-to-profound sensorineural hearing loss on societal related outcomes (participation; communication profile; autonomy; cognition; listening effort; work… Read more about this study

Who is it for?
Ages 18 years and older
How many people
156 participants
Where
5 sitesNetherlands
Study dates
29 Jun 2020to Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: People with moderate-severe to profound hearing loss who are referred to a tertiary hospital for potentially receiving a cochlear implant.

Who may be able to join

  • Adults (potentially) eligible for CI according to the Dutch quality standard for CI (Veldnorm CI 2013) and willing to participate. Participants are divided in 2 age categories (under and over 65 years old)

Who cannot join

  • People with a complex syndrome with multiple problems.
  • Incapable of performing paid or unpaid labor, due to non-hearing related factors
  • Prelingual onset of deafness.
  • Children 0 - 18 years old.
  • Non-native Dutch speakers.
  • Patients suffering from a psychiatric disorder
  • Any condition that may hamper a complete insertion of the electrode array or a normal rehabilitation with the cochlear implant (severe otosclerosis or neurologic deficits)

Trial locations and contacts

5 sites in 1 country.

Wendy Huinck contact

+316 024 361 1111

Wendy.huinck@radboudumc.nl

5 sites in 1 country

Netherlands5 sites, 5 recruiting

  • Amsterdam UMC

    Amsterdam, North Holland, 1117

    Recruiting

  • Leids UMC

    Leiden, South Holland, 2333 ZA

    Recruiting

  • Maastricht UMC+

    Maastricht, Limburg, 6229 HX

    Recruiting

  • Radboudumc

    Nijmegen, Gelderland, 6525 GA

    Recruiting

  • UMC Utrecht

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

About this study

Official title: Societal Merit of Intervention on Hearing Loss Evaluation - Investigating the Impact of (Waiting for) Cochlear Implantation in People With Severe to Profound Sensorineural Hearing Loss on Societal Related Outcomes.

The primary objective of this study is to determine the (long term) effect of intervention with a CI in adult participants with progressive postlingual moderate/severe-to-profound sensorineural hearing loss on societal related outcomes (participation; communication profile; autonomy; cognition; listening effort; work; productivity loss; income; medical consumption; third party quality of life; quality of life, and capability).

The secondary objective is to determine the effect of CI waiting time between referral and CI surgery on the same societal related outcomes, in the adults with postlingual moderate/severe-to-profound sensorineural hearing loss.

Read the detailed description

Cochlear implantation (CI) is a surgical intervention to improve the hearing of patients with profound hearing loss. Due to the improvements in CI-technology and knowledge regarding surgery and CI fitting, speech recognition with CI has improved over the past decades. This has led to relaxation of the audiological implantation criteria. Whereas CI was initially indicated for patients with total deafness, currently also patients with moderate/severe-to-profound hearing loss are eligible for CI.

Moderate/severe-to-profound hearing loss has a negative effect on the patients' functioning. Because often hearing loss in adults is progressive, resulting in a decline in speech recognition, the disability might progress during this waiting time to a state in which societal participation can become even more difficult: the hearing loss might affect social participation, autonomy, work/occupational status and quality of life. However empirical data on this is not yet available. Timely intervention, like cochlear implantation may prevent societal drop out.

The societal impact of cochlear implantation for patients who are (currently) eligible for CI is unknown. It is imperative to obtain this data in order to secure treatment for those who need it. This multicenter cohort observational study is set up to investigate the impact of moderate/severe-to-profound hearing loss on societal related outcomes, defined as participation; communication profile; autonomy; cognition; listening effort; work; productivity loss; income; medical consumption; third party quality of life; quality of life, and capability. The primary aim is to investigate the effect of hearing rehabilitation with cochlear implantation on these societal related outcomes.

Castoredc (Castor electronic data capture) will be used for capturing research data. Questionnaires will be constructed in castors' online survey service and administered to participants online.

IBM SPSS Statistics and R studio software will be used for the statistical analysis. Descriptive analysis will be conducted to assess the baseline characteristics and the continuous variables will be summarized with mean ± SD or median (interquartile range) (if not normally distributed) and categorical variables with percentage (numbers). The statistical analysis for the primary objective, the differences in baseline(T0) and T2/T3/T4 for the primary outcome variables, we will use general linear models with the outcome (differences) as independent variable. To investigate the complete pattern in time of the effects we will use mixed models, in which time is an additional explanatory categorical variable. For the secondary objective the effect between baseline(T0) and T1, short before CI surgery will be investigated. General linear models with the outcome (differences) as independent variable.

Keywords
Cochlear Implantation
Medical subject headings
Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Participation

    Sub-scales ('family role', 'Social life and relationships' and 'work and education') of The Impact on Participation and Autonomy questionnaire (IPA).There are 4 response options for each of the 32 items about participation and autonomy. These response options range from 'very good' (score=0) to 'bad' (score =4). There are 3 response options for the items about problem experiences. These range from 'no problem' (score=0) to 'big problem'(score=2). The scores of the 32 options will be summarized per sub-scale.

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

Secondary outcomes (17)

  1. Change in Autonomy

    Sub-scales ('Autonomy indoors' and 'Autonomy outdoors') of The Impact on Participation and Autonomy questionnaire (IPA)

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  2. Change in Communication profile

    Amsterdam questionnaire for Hearing and Work. Subscales derived from the Communication Profile for Hearing Impaired (CPHI) questionnaire: 'use of communication strategies' consists of: Maladaptive Behaviors; Verbal Strategies and Non-verbal Strategies

    'Personal adjustment to hearing impairment' consists of: Self-acceptance; Acceptance of loss; Stress an Withdrawal.

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  3. Change in Work experience and status

    Amsterdam questionnaire for Hearing and Work.Three scales: Subscales originated from the Vragenlijst Beleving en Beoordeling van de Arbeid (VBBA) [Questionnaire on Experience and appreciation of labor]. Subscale are: participation ['inspraak'], relationship with co-workers [relatie met collega's], Need for recovery [herstelbehoefte].

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  4. Change in Work capabilities

    List Work Capabilities. Sum score of total capability set for work. Because people want to achieve personal important goals and values in their work the List Work Capabilities (LWC) measures sustainable employability based on seven important labor values that are identified in previous studies. The scope of the LWC is not on health or broader economic indicators such as (sick leave) costs and benefits, rather it investigates values that the employee can realize in their specific work context.

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  5. Change in Productivity Costs Questionnaire

    The Productivity Cost Questionnaire (PCQ). Health problems often have a negative impact on the capacity for patients to maintain paid or unpaid work. From a societal perspective this productivity loss has an impact and should therefore be measured in a validated manner. The PCQ consists of 3 modules: absenteeism, presenteeism and Productivity loss at unpaid work.

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  6. Change in Medical Consumption Questionnaire

    In economic evaluations it is important to include direct costs within the healthcare system. These costs are directly related to prevention, diagnostics, therapy, rehabilitation and care of a disease or disorder. Patients are involved in their resource (health care) consumption and are therefore a reliable source of information. The consumption of health care in a variety of costs components will be investigate by the use of the medical consumption questionnaire.

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  7. Change in Capability

    ICECAP-A. The ICECAP-A is a measure of capability for adults. The ICECAP focuses on wellbeing defined in a broader sense, rather than health. It is a questionnaire that comprises 5 attributes. Attachment, Stability, Achievement, Enjoyment, Autonomy.

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  8. Change in Generic Quality of Life (EQ5D-5L)

    EuroQol five-dimension scale questionnaire (EQ5D-5L)

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  9. Change in Generic Quality of Life (HUI-3)

    Health Utility Index Mark 3 (HUI-3)

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  10. Change in Third Party Hearing loss related quality of life measured by Hearing Impairment Impact-Significant Other Profile (HII-SOP).

    The HII-SOP is a 20-item scale with three subscales: 1) Emotions that arise when having a spouse with hearing loss as well as the impact of the hearing loss on the marital relationship, 2) The impact of the hearing loss on the social life of the spouse, and 3) the communication strategies used by the spouse

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  11. Change in Disease specific Quality of Life measured by Nijmegen Cochlear Implant Questionnaire (NCIQ)

    Comprising of subdomains; Basic sound perception; Advanced sound perception; Speech production; Self-esteem; Activity limitations; Social interaction.

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  12. Change in Income (source)

    Questions investigating the sources of income and selecting income brackets.

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  13. Change in Cognition

    Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired (RBANS-H).This cognitive test assesses five cognitive domains; Immediate Memory, Visuospatial/constructional, Language, Attention and Delayed Memory. Within these domains there are 12 subtests. Subdomain scores and total scores will be calculated at various time points. This tests will be conducted in participants included in one of the centers.

    Measured: Once between study inclusion and surgery (pre-operative), 1 year post surgery, and (if participant is over 65 years old) 2 years post surgery.

  14. Change in Listening effort

    Listening effort will be assessed in a sub-population of participants under 65 by using pupillometry

    Measured: 4 weeks after surgery and 1 year after surgery.

  15. Change in Linguistic skills by Vocabulary test

    Adaptive Vocabulary test STAIRS4WORDS developed by the Max Planck Institute for Psycholinguistics.

    Measured: Once between inclusion and surgery.

  16. Change in Tinnitus

    Measured by the THI (Tinnitus Handicap Inventory)

    Measured: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

  17. Change in quality of life score post-intervention

    Measured by The Glasgow Benefit Inventory (GBI)

    Measured: T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start29 Jun 2020
  3. Primary completionOct 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05525221
Sponsor's protocol ID
2019-6057
Acronym
SMILE
Status last verified
Aug 2022
First submitted
25 Aug 2022
Last updated
1 Sep 2022
Results posted
No

Publications

  • Beckers L, Nijmeijer H, Mylanus E, Huinck W. Investigating the association between pre-implantation cognitive performance and one-year post-implantation speech perception outcomes in adult cochlear implant recipients using the repeatable battery for the assessment of neuropsychological status for hearing impaired individuals (RBANS-H). Cochlear Implants Int. 2026 Jan;27(1):32-43. doi: 10.1080/14670100.2025.2601419. Epub 2025 Dec 22.

    PubMed 41431315

  • Nijmeijer HGB, Philpott N, van der Wilt GJ, Donders ART, George E, Boerboom R, Frijns JHM, Kaandorp M, Huinck WJ, Mylanus EAM. Changes in participatory and societal outcomes during the waiting period for cochlear implantation - an observational study. Eur Arch Otorhinolaryngol. 2025 Feb;282(2):753-764. doi: 10.1007/s00405-024-08981-7. Epub 2024 Sep 26.

    PubMed 39327291

  • Nijmeijer HGB, Huinck WJ, Kramer SE, Donders ART, van der Wilt GJ, Mylanus EAM. Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study - Societal Merit of Intervention on Hearing Loss Evaluation (SMILE). BMJ Open. 2023 Jun 27;13(6):e072689. doi: 10.1136/bmjopen-2023-072689.

    PubMed 37369408

Questions about this trial

What is this clinical trial studying?

An observational study of Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by Radboud University Medical Center at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wendy Huinck (+316 024 361 1111, Wendy.huinck@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Participation (time frame: T0 (baseline), T1 (pre-operative, if waiting time > 6 months), T2 (1 year post CI surgery), T3 (2 years post CI surgery), T4 (3 years post CI surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05525221, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.

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