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临床试验/NCT03552302
NCT03552302已完成不适用

Effects of Yoga Exercise on Tinnitus Handicap and Sleep Quality of the Participates With Tinnitus

Dalin Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Change from Assessment of the degree of tinnitus

研究概览

简要总结

This study aimed to investigate the effectiveness of Yoga on the tinnitus handicap and sleep quality in humans. We selected adult participates with chronic tinnitus (>6 months). All participates performed Yoga exercise once per week at outpatient department under the guidance of a professional teacher, and performed once daily by themselves at home for 12 weeks. Questionnaires of Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index were measured before the start of this study, at the end of this study, and 1 month after the end of this study.

详细描述

Tinnitus is the auditory phantom sensation in the absence of external sound stimulation. Tinnitus that persisted more than six months without improvement can be called chronic tinnitus. One report proposed the neurophysiological model of tinnitus. In addition, tinnitus patients suffered from insomnia, irritability, anxiety and/or depression.

Current management of tinnitus is a drug-based treatment and/or nutritional supplementation. Music therapy, hearing aid therapy, and tinnitus retraining therapy (TRT), were also applied for patients with tinnitus. Even though, success rates of various tinnitus treatments were still unsatisfactory till now.

This study aimed to investigate the effectiveness of Yoga on the tinnitus handicap and sleep quality in humans. We selected adult participates with chronic tinnitus (>6 months). All participates performed Yoga exercise once per week at outpatient department under the guidance of a professional teacher, and performed once daily by themselves at home for 12 weeks. Questionnaires of Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index were measured before the start of this study, at the end of this study, and 1 month after the end of this study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participates with tinnitus persisted more than 6 months from ear, nose, and throat out-patient department.
  • No drug treatment for their tinnitus in recent 3 months.
  • No respiratory diseases (eg, asthma).
  • Normal cognitive function.
  • Normal language comprehension.

排除标准

  • Pregnant females or menopausal females with hormone replacement therapy.
  • Hypertension
  • Those who cannot express their opinions or follow orders.
  • Cancer patients.
  • Objective tinnitus.

结局指标

主要结局

Change from Assessment of the degree of tinnitus

时间窗: 1. One week before yoga intervention. 2. Through study completion, an average of 12 week. 3. One month after the end of the study.

Chinese version of Tinnitus Handicap Inventory (THI). There were 25 questions and totally 100 points in THI. The answer for each questions is classified into three levels (will, sometimes, will not), and answering "will" gave 4 points, answering "sometimes" gave 2 points, and answering "will not " gave 0 points. The higher the total scores, the more severe the tinnitus.

次要结局

  • Assessment of the degree of sleep quality.(1. One week before yoga intervention. 2. Through study completion, an average of 12 week. 3. One month after the end of the study.)

研究者

发起方
Dalin Tzu Chi General Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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