跳至主要内容
临床试验/NCT01999855
NCT01999855终止不适用

Evaluation of the Frequency of Dysphonia by Subjective and Objective Methods in Asthmatic Patients

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
137
试验地点
2
主要终点
Evidence of dysphonia. The patient will be considered as having a dysphonia if at least one of the tests (Voice Handicap Index, Rank Rough Breathy Asthenic Strained GRBAS, Quotien Phonatoire QP and Fundamental laryngeal F0) is abnormal

研究概览

简要总结

For many years, it is known that asthmatics have more often dysphonia. However, no study has so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests.

The etiology of dysphonia in asthmatic remains controversial. Indeed, for a long time, inhaled corticosteroids have been considered as responsible for organic abnormalities of the vocal cords. We hypothesized that women with asthma have more often dysphonia, and that dysphonia is rather functional origin.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged between 18 to 65 years
  • Patient who signed the informed consent.
  • affiliated with a social security system.
  • Patients with asthma (GINA criteria)
  • persistent asthma with inhaled corticosteroids.

排除标准

  • 未提供

研究组 & 干预措施

control group

Active Comparator
  • the Phonatory Maximum Time
  • Vocal Handicap Index
  • Scale GRBAS of Hirano
  • Videolaryngoscopy

干预措施: Phoniatric tests (Other)

Asthmatic patients

Experimental
  • The Phonatory Maximum Time
  • Vocal Handicap Index
  • Scale GRBAS of Hirano
  • Videolaryngoscopy

干预措施: Phoniatric tests (Other)

结局指标

主要结局

Evidence of dysphonia. The patient will be considered as having a dysphonia if at least one of the tests (Voice Handicap Index, Rank Rough Breathy Asthenic Strained GRBAS, Quotien Phonatoire QP and Fundamental laryngeal F0) is abnormal

时间窗: Four week

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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