Hearing Aids Use in Elderly: Efficacy in Speech Perception and in Health-related Quality of Life - Trial NCT04333043
Access comprehensive clinical trial information for NCT04333043 through Pure Global AI's free database. This phase not specified trial is sponsored by Azienda Unità Sanitaria Locale di Piacenza and is currently Recruiting. The study focuses on Hearing Loss, Age-Related. Target enrollment is 100 participants.
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Study Focus
Sponsor & Location
Azienda Unità Sanitaria Locale di Piacenza
Timeline & Enrollment
N/A
Feb 07, 2018
Dec 31, 2021
Primary Outcome
Improvement in speech recognition in noise with audiometrical test,Improvement in speech recognition in noise with OLSA test
Summary
Background: Prevalence of hearing loss increases over age; its estimated prevalence is 40-50%
 in people older than 75 years. Recent studies agree that modification in the hearing
 threshold contributes to deterioration in sociality, sensitivity, cognition, and quality of
 life of the elderly subjects.
 
 Our study objective is to verify if rehabilitation with first time applied Hearing Aids (HA)
 in a cohort of old people with hearing impairment improves over time speech perception in a
 noisy environment and the overall health-related quality of life.
 
 Methods: The monocentric, prospective, repeated measures, single-subject, clinical
 observational study will accrue 100 elderly, first-time HA recipients (≥ 65 years). The
 evaluation protocol is designed to analyze changes on specific measurement tools a year after
 the first HA fitting in comparison to the evaluation before HA usage.
 
 Evaluations will consist of multiparametric details collected through self-report
 questionnaires completed by the recipients and a series of commonly used audiometric measures
 and geriatric assessment tools. The primary indicator of changes in speech perception in
 noise will be the OLSA test whereas the indicator of changes in overall quality of life will
 be the AQoL and HHEI questionnaires. Montreal Cognitive Assessment (MoCA) will help us to
 verify the cognitive state of the subjects. This questionnaire will allow us to exclude a
 reduction of the cognitive abilities over time.
 
 Discussion: The protocol is designed to make use of measurement tools that have already been
 applied to the hearing-impaired population in order to compare the effects of HA
 rehabilitation in the elderly immediately before their first HA usage (Pre) and after gaining
 1 year of experience (Post). The broad approach will lead to a greater understanding of how
 useful hearing influences the quality of life in elderly individuals, and thus improves
 potentials for healthy aging. Outcomes will be described and analyzed in detail.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04333043
Non-Device Trial