The RBANS-H in Older Adults With Normal Hearing or Age-related Hearing Loss (RBANS-H_ARHL)

July 3, 2017 updated by: Ethisch Comité UZA, University Hospital, Antwerp

The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) in Older Adults With Normal Hearing or Age-related Hearing Loss

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Annes J. Claes, MSc
        • Sub-Investigator:
          • Griet Mertens, prof PhD
        • Sub-Investigator:
          • Annick Gilles, prof PhD
        • Sub-Investigator:
          • Anouk Hofkens, BSc
        • Sub-Investigator:
          • Vincent Van Rompaey, prof PhD MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal hearing older adults
Older adults with normal hearing or age-related hearing loss
Diagnostic test: RBANS-H
The RBANS-H is a diagnostic cognitive test battery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RBANS-H total scaled score
Time Frame: Baseline
The RBANS-H assess cognition and provides one total score of cognition.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RBANS-H index scores
Time Frame: Baseline
The RBANS-H assesses five cognitive domains (Immediate Memory, Visuospatial/constructional, Language, Attention and Delayed Memory). The test consists of twelve subtests and the score on each subtest contributes to one of the five domains.
Baseline
Free field best aided speech in noise audiometry: Speech Reception Threshold (SRT)
Time Frame: Baseline
The speech reception in noise is assessed by means of the Leuven Intelligibility Sentences Test (LIST) using an adaptive procedure. This speech material is developed to quantify the speech understanding in subjects with severely impaired hearing. The frequency spectrum of the noise signal is equal to the long-term average speech spectrum of the sentences. The level of the noise is fixed at 65 dB SPL, while the level of the speech signal is altered depending on the response of the patient. Each list consists of ten sentences and the speech reception threshold (SRT) is calculated as the mean level of the last five sentences together with the level of the imaginary 11th sentence of the list. This speech in noise test is performed both pre- and postoperatively in an aided, free field situation with the loudspeaker in front of the subject at a distance of one meter.
Baseline
Free field best aided speech in quiet audiometry (phoneme score): SRT
Time Frame: Baseline
Speech reception in quiet is measured using Dutch open-set word lists. Each list consists of twelve monosyllabic words (consonant-vowel-consonant) of which one is a training item. The lists are presented at 65, 55, 40, 30, 20 and 10 dB SPL in free field with a loudspeaker at 0° azimuth. The intensity at which 50% of the phonemes is received correctly, is the SRT.
Baseline
Free field best aided hearing thresholds: Fletcher Index (FI)
Time Frame: Baseline
The best aided thresholds with no, one or two hearing aid(s) are measured through free field audiometry with warble tones. The loudspeaker is placed at a distance of one meter in front of the subject at ear level.
Baseline
Health Utilities Index-2/3 (HUI 2/3)
Time Frame: Baseline
The HUI questionnaire measures the self-perceived health status of the participant and rates the health-related quality of life (HRQL). The questionnaire consists of 17 items with four to six options. The HRQL scoring systems provide utility (preference) scores on a generic scale where dead = 0.00 and perfect health = 1.00.
Baseline
Dizziness Handicap Inventory (DHI)
Time Frame: Baseline
The DHI is used to quantify the impact of dizziness on everyday life. This 25-item questionnaire was developed to assess the self-perceived handicapping effects imposed by vestibular system disorders. Each item is rated as Yes = 4, Sometimes = 2 or No = 0 and contributes to one of three subscales, namely Functional, Emotional and Physical. A total score is calculated adding the scores on each item.
Baseline
General questionnaire
Time Frame: Baseline
A non-validated general questionnaire on education and profession, medical history, hearing aid use and tinnitus
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: Paul Van de Heyning, prof PhD MD, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

June 23, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 5, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/43/450

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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