CTRI/2026/01/101670尚未招募不适用
A Comparative Study To Evaluate The Effectiveness Of Vagus Nerve Stimulation Exercises And Aerobic Exercises On Heart Rate Variability And C- reactive Proteins Levels In Individuals With Secondary Insomnia
Dr. Jagruti Sharma [PT]1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年2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
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- C- reactive protein levels
研究概览
简要总结
Insomnia is a prevalent sleep disorder associated with autonomic hyperarousal and inflammation, often reflected by altered heart rate variability (HRV) and elevated C-reactive protein (CRP). This 6-week randomised clinical trial aims to compare the effectiveness of manual vagus nerve stimulation exercises and aerobic exercises in individuals with secondary insomnia. Participants will be equally and randomly allocated, and outcomes will be measured using HRV, CRP levels, and the Pittsburgh Sleep Quality Index (PSQI) on day 0,21,42.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 26.00 Year(s)（—）
- 性别
- All
入选标准
- •All subjects with insomnia having a score of more than 5, which indicates poor sleep quality, according to Pittsburgh Sleep Quality Index (PSQI) P-young individuals I-vagus nerve stimulation exercise ,cognitive behavioral therapy, aerobic exercises C-vagus nerve stimulation exercise and aerobic exercise O –Heart rate variability, C-reactive protein , Pittsburgh sleep Quality Index Secondary insomnia patients were included in the study who are having psychosomatic illness.
排除标准
- •Subjects having any autoimmune condition , recent cold and cough, any inflammatory condition , sinusitis ,recent surgeries ,cardiac condition were excluded Older adults and geriatric population were excluded.
结局指标
主要结局
C- reactive protein levels
时间窗: At day 0 and day 42
Heart rate variability
时间窗: At day 0 and day 42
次要结局
- Pittsburgh Sleep Quality Index(At day 0, day 21 and day 42)
研究者
Jagruti Sharma
Jaipur National University
研究点 (1)
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