NCT03208608

Brief Summary

The present cross-sectional study aims to examine the cognitive capabilities of older adults, aged 50 to 89, with normal hearing or age-related hearing loss by means of the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals (RBANS-H). Secondly, the correlations between cognition on the one hand and hearing and speech reception capabilities on the other hand are investigated. For this purpose, twenty participants are included in the age categories 50 to 59, 60 to 69, 70 to 79 and 80 to 89, bringing the total number to 80. Three questionnaires are administered to the participants: the Health Utilities Index-2/3 (HUI 2/3), Dizziness Handicap Inventory (DHI) and a general questionnaire on education and profession, medical history, hearing aid use and tinnitus. Also an audiological examination is performed, including pure tone audiometry, speech in quiet and speech in noise audiometry. Finally, cognition is assessed using the RBANS-H.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 5, 2017

Status Verified

July 1, 2017

Enrollment Period

10 months

First QC Date

June 23, 2017

Last Update Submit

July 3, 2017

Conditions

Keywords

RBANS-HOlder adultsNormal hearingCognitionAge-related hearing loss

Outcome Measures

Primary Outcomes (1)

  • RBANS-H total scaled score

    The RBANS-H assess cognition and provides one total score of cognition.

    Baseline

Secondary Outcomes (7)

  • RBANS-H index scores

    Baseline

  • Free field best aided speech in noise audiometry: Speech Reception Threshold (SRT)

    Baseline

  • Free field best aided speech in quiet audiometry (phoneme score): SRT

    Baseline

  • Free field best aided hearing thresholds: Fletcher Index (FI)

    Baseline

  • Health Utilities Index-2/3 (HUI 2/3)

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

Normal hearing older adults

Older adults with normal hearing or age-related hearing loss

Diagnostic Test: RBANS-H

Interventions

RBANS-HDIAGNOSTIC_TEST

The RBANS-H is a diagnostic cognitive test battery

Normal hearing older adults

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults aged 50 to 89 with hearing thresholds according to their age and without history of any neurological or otological diseases

You may qualify if:

  • Hearing: Air conduction hearing thresholds according to age, based on the ISO standards
  • Age: 50 - 89

You may not qualify if:

  • History of any neurological disease
  • History of otological surgery or disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Presbycusis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Paul Van de Heyning, prof PhD MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Van de Heyning, prof PhD MD

CONTACT

Annes J. Claes, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 23, 2017

First Posted

July 5, 2017

Study Start

November 21, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 5, 2017

Record last verified: 2017-07

Locations