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

Normal Hearing Clinical Trial

— RBANS-H_ARHL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03208608
• Other study ID #: 16/43/450
• Status: Recruiting
• Phase: N/A
• First received: June 23, 2017
• Last updated: July 3, 2017
• Start date: November 21, 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2017
• Source: University Hospital, Antwerp
• Contact: Paul Van de Heyning, prof PhD MD
• Phone: 0032 3 821 47 30
• Email: paul.van.de.heyning[@]uza.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Normal Hearing
• Presbycusis

Intervention

Diagnostic Test:
• RBANS-H
The RBANS-H is a diagnostic cognitive test battery

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RBANS-H total scaled score	The RBANS-H assess cognition and provides one total score of cognition.	Baseline
Secondary	RBANS-H index scores	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
Secondary	Free field best aided speech in noise audiometry: Speech Reception Threshold (SRT)	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
Secondary	Free field best aided speech in quiet audiometry (phoneme score): SRT	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
Secondary	Free field best aided hearing thresholds: Fletcher Index (FI)	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
Secondary	Health Utilities Index-2/3 (HUI 2/3)	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
Secondary	Dizziness Handicap Inventory (DHI)	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
Secondary	General questionnaire	A non-validated general questionnaire on education and profession, medical history, hearing aid use and tinnitus	Baseline