跳至主要内容
临床试验/CTRI/2025/02/081114
CTRI/2025/02/081114尚未招募不适用

HearIT - A low cost hearing screening device

ICMR1 个研究点 分布在 1 个国家目标入组 614 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
ICMR
入组人数
614
试验地点
1
主要终点
The primary outcome of the study is to determine the signal to noise ration and percentage of individuals passing or failing the screening test with experimental and standard devices. Subsequently, it will be employed to calculate sensitivity, specificity, positive predictive value, and negative predictive value.

研究概览

简要总结

Hearing impairment is one of the serious disabilities but is often neglected in India. The individual with hearing loss in the country often suffer due to lower wages and inadequacy of facilities for them. This causes more financial burden and higher unemployment rate. The neonatal hearing screening (NHS) programme is universally recommended and accepted means for early identification and intervention of congenital hearing loss. Initially targeted for babies at high risk, Universal Neonatal Hearing Screening (UNHS) now stands for arrangement of, screening every neonate born in the hospital. The implementation of UNHS has been shown to reduce the age of identification of hearing impairment significantly and minimize the overall effect of hearing loss on an individual’s life. In India, the programme implementation is still in initial phase and monitoring children as well as adults regularly is almost non-prevalent. This can be majorly attributed to currently available expensive hearing screening devices. Further, such equipment may only be used by specialists such as audiologists, who are in shortage. In this project we will completely re-engineer such a screening device in order to significantly bring down its cost, enable it to be used by laypersons in the same manner that we use blood pressure monitors or thermometers and make suitable for use in different surroundings without requiring a no-ambient noise setting. More widespread availability of low-cost screening devices will enable their usage in schools, small healthcare centres, factories and construction sites. This in turn will help with the detection of hearing impairment and the affected individuals may be referred for treatment early on, thereby significantly improving the chances of recovery and prevent further deterioration.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Individual with and without Hearing loss within the specified age range.

排除标准

  • Patients Not willing to participate in the study.

结局指标

主要结局

The primary outcome of the study is to determine the signal to noise ration and percentage of individuals passing or failing the screening test with experimental and standard devices. Subsequently, it will be employed to calculate sensitivity, specificity, positive predictive value, and negative predictive value.

时间窗: The outcomes of both the devices will be evaluated at the end of data collection.

次要结局

  • The Secondary outcome of the study will be comparative values of sensitivity, specificity, positive predictive & negative predictive values using both the devices in different age groups.(All the analysis will be perform at the end of data collection.)

研究者

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Kapil Sikka

AIIMS, New Delhi

研究点 (1)

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