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临床试验/NCT03235466
NCT03235466Unknown不适用

A Prospective Trial of Behavioral Therapy for Chronic Cough

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
试验地点
2
主要终点
Percentage of Cough reduction

研究概览

简要总结

This study seeks to explore whether heart rate variability (HRV) biofeedback can be effective in the treatment of chronic cough. Chronic cough has many causes, including asthma, postnasal drip, and gastroesophageal reflux disease (GERD), each with a specific treatment. However, among a subset of cough patients, no clear cause is found despite extensive workup, and traditional treatment methods do not provide relief. Several studies revealed less common causes of chronic cough and disordered breathing such as vagal neuropathy, paradoxical vocal fold motion, and stress. Additional research identified links between the neurological networks that produce the cough reflex and those that maintain normal breathing. HRV biofeedback is a self-regulation technique that uses computer equipment to monitor heart rate and breathing, two key functions of the autonomic nervous system. By using this non-invasive behavioral technique, cough patients can regulate their breathing and autonomic function, potentially leading to improved autonomic balance and a reduction in cough symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 8+ weeks of cough, Fluent English speaker, Have access to an electronic mobile device

排除标准

  • On neuromodulator therapy, cardiac arrhythmia, dysphagia, prior HRVB or mindfulness, head and neck surgery of the oropharynx, neck or larynx, lung surgery, pulmonary pathology other than asthma, tourette syndrome, ACE inhibitor use, current or recent smoker.
  • Added exclusion criteria as of March 2020 - history of COVID+.

结局指标

主要结局

Percentage of Cough reduction

时间窗: 3 weeks

Measured by changes in cough severity index and patient recordings

次要结局

  • Durability of cough remediation(8 weeks)
  • Changes in dyspnea(3 weeks)
  • Change in voice(3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Philip Weissbrod

Director, Center for Voice and Swallowing

University of California, San Diego

研究点 (2)

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