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Hearing intervention for decreasing risk of developing dementia in elders with mild cognitive impairment: study protocol of a multicenter randomized controlled trial for Chinese Hearing Solution for Improvement of Cognition in Elders (CHOICE)

Authors :
Ying Chen
Lei Guan
Jie Chen
Kun Han
Qiongfei Yu
Jin Zhou
Xue Wang
Yunqian Ma
Xiangyu Ji
Zhonglu Zhao
Qiyue Shen
Anxian Wang
Mengping Wang
Jin Li
Jiali Yu
Yiwen Zhang
Sijia Xu
Jie Liu
Wen Lu
Bin Ye
Yuan Fang
Haixia Hu
Haibo Shi
Mingliang Xiang
Xia Li
Yun Li
Hao Wu
Source :
Trials, Vol 24, Iss 1, Pp 1-11 (2023)
Publication Year :
2023
Publisher :
BMC, 2023.

Abstract

Abstract Background Age-related hearing loss (ARHL) signifies the bilateral, symmetrical, sensorineural hearing loss that commonly occurs in elderly individuals. Several studies have suggested a higher risk of dementia among patients diagnosed with ARHL. Although the precise causal association between ARHL and cognitive decline remains unclear, ARHL has been recognized as one of the most significant factors that can be modified to reduce the risk of developing dementia potentially. Mild cognitive impairment (MCI) typically serves as the initial stage in the transition from normal cognitive function to dementia. Consequently, the objective of our randomized controlled trial (RCT) is to further investigate whether the use of hearing aids can enhance cognitive function in older adults diagnosed with ARHL and MCI. Methods and design This study is a parallel-arm, randomized controlled trial conducted at multiple centers in Shanghai, China. We aim to enlist a total of 688 older adults (age ≥ 60) diagnosed with moderate-to-severe ARHL and MCI from our four research centers. Participants will be assigned randomly to either the hearing aid fitting group or the health education group using block randomization with varying block sizes. Audiometry, cognitive function assessments, and other relevant data will be collected at baseline, as well as at 6, 12, and 24 months post-intervention by audiologists and trained researchers. The primary outcome of our study is the rate of progression to dementia among the two groups of participants. Additionally, various evaluations will be conducted to measure hearing improvement and changes in cognitive function. Apart from the final study results, we also plan to conduct an interim analysis using data from 12-month follow-up. Discussion In recent years, there has been a notable lack of randomized controlled trials (RCTs) investigating the possible causal relationship between hearing fitting and the improvement of cognitive function. Our findings may demonstrate that hearing rehabilitation can be a valuable tool in managing ARHL and preventing cognitive decline, which will contribute to the development of a comprehensive framework for the prevention and control of cognitive decline. Trial registration Chinese Clinical Trial Registry chictr.org.cn ChiCTR2000036139. Registered on 21 August 2020.

Details

Language :
English
ISSN :
17456215
Volume :
24
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Trials
Publication Type :
Academic Journal
Accession number :
edsdoj.16f1b68d4b4e4aa2a03af16ecc0ae7ea
Document Type :
article
Full Text :
https://doi.org/10.1186/s13063-023-07813-z