NCT05273190招募中不适用
Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assess usability of VTS device
研究概览
简要总结
Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-88
- •>8 weeks of cough
- •Cough visual analogue scale (VAS): Rating of 30 or greater on a 0-100 cough severity scale
- •Ability to provide informed consent and independently complete questionnaires
- •Ability to read and speak English
排除标准
- •Electronic implants (e.g., pacemaker)
- •Currently doing speech therapy for cough
- •Contraindications to safe or effective VTS device use
- •No regular access to wifi internet Neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA, vocal fold paralysis or paresis)
- •Untreated carotid disease
- •BMI > 40 (for transmission of VTS through soft tissue)
- •Current or recent (quit < 3 months ago) smoking
- •Known currently infectious cause for cough (e.g., TB, pertussis, COVID)
- •History of known or suspected aspiration pneumonia
- •Diagnosis or clinical suspicion of chronic obstructive pulmonary disease (COPD)
- •Diagnosis or clinical suspicion of interstitial lung disease (ILD)
- •Unmanaged reflux
- •Unmanaged allergies/postnasal drip
研究组 & 干预措施
Vibrotactile Stimulation
Experimental
干预措施: Vibrotactile Stimulation (Device)
结局指标
主要结局
Assess usability of VTS device
时间窗: 3-7 weeks
% of participants indicating agree or strongly agree with statements of usability
Impact of VTS on cough symptoms
时间窗: 3-7 weeks
Pre-post comparison of LCQ scores
次要结局
未报告次要终点
研究者
研究点 (1)
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