NCT05525221

Brief 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; 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

5.3 years

First QC Date

August 25, 2022

Last Update Submit

August 30, 2022

Conditions

Hearing Loss, SensorineuralHearing Loss, BilateralHearing Loss, Adult-OnsetHearing Loss, Bilateral Sensorineural, Progressive

Keywords

Cochlear Implantation

Outcome Measures

Primary Outcomes (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.

    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)

  • Change in Autonomy

    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)

  • Change in Communication profile

    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)

  • Change in Work experience and status

    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)

  • Change in Work capabilities

    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)

  • Change in Productivity Costs Questionnaire

    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 more secondary outcomes

Other Outcomes (4)

  • Change in Audiological outcomes Tone thresholds

    Pre-surgery and 1 year post-surgery

  • Change in Audiological outcomes speech perception score unaided by using NVA lists and CVC words/phonemes.

    Pre-surgery and 1 year post-surgery

  • Change in Audiological outcomes speech perception score aided by using NVA lists and CVC words/phonemes.

    Pre-surgery and 1 year post-surgery

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Maastricht UMC+

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1117, Netherlands

RECRUITING

Leids UMC

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

UMC Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Related Publications (3)

  • 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. 2025 Dec 22:1-12. doi: 10.1080/14670100.2025.2601419. Online ahead of print.

    PMID: 41431315DERIVED

  • 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.

    PMID: 39327291DERIVED

  • 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.

    PMID: 37369408DERIVED

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing Loss, BilateralHearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emmanuel Mylanus

    Radboud University Medical Center

    STUDY DIRECTOR

Central Study Contacts

Wendy Huinck

CONTACT

+316 024 361 1111Wendy.huinck@radboudumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2022

First Posted

September 1, 2022

Study Start

June 29, 2020

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations

NL(5)