跳至主要内容
临床试验/CTRI/2023/06/053390
CTRI/2023/06/053390尚未招募不适用

A study on frailty, cognitive dysfunction and associated comorbidities with Hearing loss in Geriatric population

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年1月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
1
主要终点
The study is expected to give the overview of the hearing impairment diagnosis and management of hearing impairment in older adults along with the other comorbidities. The study will highlight the impact of other physical and mental condition and the limitation that it imposes on the diagnosis of hearing loss as well as the rehabilitation process with the appropriate hearing assistive device such as hearing aids. It will help us to analyse the factors pertaining to the other health conditions that play a major role in management of hearing loss in these individuals. We expect to establish a correlation between general poor mental and physical health in patients with hearing loss compared to those without it. Also, cognitive domain is likely to be significantly impaired in hearing loss group of individuals.

研究概览

简要总结

Hearing loss is one of the most common sensory deficits in older adults. It significantly affects the quality of life and needs equal attention. However, the diagnosis and rehabilitation of hearing impairment in older adults is not independent of other comorbidities expected in this group. The identification of hearing loss, diagnosis through proper test battery and rehabilitation with appropriate hearing device is majorly dependant on the overall physical and mental health of the individuals. Novelty: Cognitive decline and its impact on hearing impairment in older adults is being studied intensively. However, fewer researches have focused on overall health and its impact on age related hearing loss in older adults. Authors and co-authors (Prof. Alok Thakar) have led the ICMR task force project investigating hearing loss in India population at various centres. A major factor causing hearing loss in India has been identified as presbycusis. There is hence a need to study geriatric hearing loss further. Objective: Therefore, this study is focused at assessing the cross section of the individuals with age >60 years who complain of hearing loss and the ones who do not have any ear related complains. Physical and mental health will be evaluated for both the cohort and its impact on diagnosis and management of hearing loss will be studied using appropriate questionnaires and standardized scales and tests. Method:  Audiological test battery including the Pure Tone Audiometry, Speech audiometry, Impedance audiometry and reflex testing will be done. Along with this the Frailty index will be calculated using the Fried criteria, disability in instrumental activities of daily living (IADL) will be measured using the Lawton and Brody scale and cognitive decline will be assessed using the Hindi Mental State Examination (HMSE). Also a questionnaire pertaining to awareness, willingness and benefits of hearing aid will be administered. All the data will be tabulated and correlation analysis will be done. Further, there is lack of data on usage assistive device and amplification device like hearing aid in hearing impaired population. Therefore, in this study as secondary objective, we wish to evaluate factors pertaining to this.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • (Group 1) -Individuals with age >60 years -Individuals without the complain of hearing loss (Group 2) -Individuals with age >60 years -Individuals with sensorineural or mixed hearing loss.

排除标准

  • (Group 1) -Individuals with ear related complain -No consent for the study (Group 2) -No consent for the study.

结局指标

主要结局

The study is expected to give the overview of the hearing impairment diagnosis and management of hearing impairment in older adults along with the other comorbidities. The study will highlight the impact of other physical and mental condition and the limitation that it imposes on the diagnosis of hearing loss as well as the rehabilitation process with the appropriate hearing assistive device such as hearing aids. It will help us to analyse the factors pertaining to the other health conditions that play a major role in management of hearing loss in these individuals. We expect to establish a correlation between general poor mental and physical health in patients with hearing loss compared to those without it. Also, cognitive domain is likely to be significantly impaired in hearing loss group of individuals.

时间窗: The first two years of the study will focus on data collection and the third year will be for the compilation and analysis of the data along with the final report writing.

次要结局

  • It will help us to analyse the factors pertaining to the other health conditions that play a major role in management of hearing loss in these individuals. We expect to establish a correlation between general poor mental and physical health in patients with hearing loss compared to those without it. Also, cognitive domain is likely to be significantly impaired in hearing loss group of individuals.(The first two years of the study will focus on data collection and the third year will be for the compilation and analysis of the data along with the final report writing.)

研究者

申办方类型
Government funding agency

研究点 (1)

Loading locations...

相似试验