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

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ClinicalTrials.gov Identifier: NCT03208608
Recruitment Status : Unknown
Verified July 2017 by Ethisch Comité UZA, University Hospital, Antwerp.
Recruitment status was:  Recruiting
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZA, University Hospital, Antwerp

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.

Condition or disease Intervention/treatment
Normal Hearing Diagnostic Test: RBANS-H

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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
Actual Study Start Date : November 21, 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. RBANS-H total scaled score [ Time Frame: Baseline ]
    The RBANS-H assess cognition and provides one total score of cognition.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. General questionnaire [ Time Frame: Baseline ]
    A non-validated general questionnaire on education and profession, medical history, hearing aid use and tinnitus



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208608


Contacts
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Contact: Paul Van de Heyning, prof PhD MD 0032 3 821 47 30 paul.van.de.heyning@uza.be
Contact: Annes J. Claes, MSc 0032 3 821 58 38 annes.claes@uza.be

Locations
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Belgium
Antwerp University Hospital Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Paul Van de Heyning, prof PhD MD    0032 3 821 47 30    paul.van.de.heyning@uza.be   
Contact: Annes Claes, MSc    0032 3 821 58 38    annes.claes@uza.be   
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         
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Paul Van de Heyning, prof PhD MD University Hospital, Antwerp
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Responsible Party: Ethisch Comité UZA, Principal investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03208608    
Other Study ID Numbers: 16/43/450
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Keywords provided by Ethisch Comité UZA, University Hospital, Antwerp:
RBANS-H
Older adults
Normal hearing
Cognition
Age-related hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Presbycusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural