CTRI/2024/12/077854招募中不适用
Assessment of Auditory and Cognitive Function in Stable Chronic Obstructive Pulmonary Disease Patients
Department of Health Research(DHR)1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年1月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- To assess Auditory functions by using Oto-acoustic emission (OAE) and Brainstem evoked response audiometry (BERA) in stable COPD patients and compare them with healthy controls
研究概览
简要总结
The Study will be a hospital based prospective cross-sectional study and participants will be stable COPD patients and age, sex matched healthy controls(40-60yeras). In this study we will test the hearing ability of all the participants by using BERA and OAE machine and then with the help of Montreal Cognitive Assessment tool questionnaire(MOCA) we will assess the cognition. Oxidative stress will be measured by MDA levels measured in blood of the patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed Stable COPD patients reporting to the respiratory department OPD Subjects with no hospitalization for COPD related illness in the last 6 months.
- •Healthy controls who are coming to the hospital with trivial illness or the attendants of patients with no history of COPD.
排除标准
- •1.Patients presenting with acute exacerbation or any other complication of COPD like Cor pulmonale
- •Any other lung diseases patients like silicosis, asbestosis, restrictive lung diseases, and emphysema.
- •Patients with history of any traumatic lesion possibly affecting auditory functions, injury to tympanic membranes due to trauma, loud noise(more than 85dB), known to have decreased hearing due to infections in middle ear, and family history of hearing loss
- •History of ear surgery, or ototoxicity, intake of ototoxic drugs.
结局指标
主要结局
To assess Auditory functions by using Oto-acoustic emission (OAE) and Brainstem evoked response audiometry (BERA) in stable COPD patients and compare them with healthy controls
时间窗: 2 years
次要结局
- To assess cognitive functions in stable COPD patients vs. age matched healthy volunteers using Montreal Cognitive assessment questionnaire (MoCA)(2 years)
研究者
Dr. ILA JOSHI
Department of Physiology, NIMS University,Rajasthan
研究点 (1)
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