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
|Condition or disease||Intervention/treatment|
|Normal Hearing||Diagnostic Test: RBANS-H|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|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|
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
- RBANS-H total scaled score [ Time Frame: Baseline ]The RBANS-H assess cognition and provides one total score of cognition.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- General questionnaire [ Time Frame: Baseline ]A non-validated general questionnaire on education and profession, medical history, hearing aid use and tinnitus
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
|Contact: Paul Van de Heyning, prof PhD MD||0032 3 821 47 firstname.lastname@example.org|
|Contact: Annes J. Claes, MSc||0032 3 821 58 email@example.com|
|Antwerp University Hospital||Recruiting|
|Edegem, Antwerp, Belgium, 2650|
|Contact: Paul Van de Heyning, prof PhD MD 0032 3 821 47 30 firstname.lastname@example.org|
|Contact: Annes Claes, MSc 0032 3 821 58 38 email@example.com|
|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|
|Principal Investigator:||Paul Van de Heyning, prof PhD MD||University Hospital, Antwerp|