A Comprehensive Evaluation of the Impact of ATP on Laryngeal Symptoms, Hypersensitivity and Function - an Observational Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in laryngeal relaxation time (seconds) during challenge testing
研究概览
简要总结
OBJECTIVES
- To deliver a comprehensive model of laryngeal assessment, evaluating both the sensory and motor components of upper airway control and to relate this to symptom disturbance.
- Determine if laryngeal control is altered by coughing and the impact of repeated coughing on overall laryngeal control and relaxation to its baseline state.
- Evaluate if cell damage and tissue inflammation (including exposure to ATP) modulates laryngeal hypersensitivity and function, by using a comprehensive array of test modalities.
AIM To utilise state-of-the-art comprehensive assessment tools to evaluate laryngeal hypersensitivity and function in a cohort of individuals with chronic refractory cough and control subjects. The test modalities utilise direct stimulation of the laryngeal adductor reflex, measurement of laryngeal EMG and assessment of functional laryngeal response to an inhalational challenge with laryngoscopic techniques.
HYPOTHESIS Physiological markers of laryngeal hypersensitivity and dysfunction are highly prevalent in patients with chronic refractory cough and manifestations are driven by ATP stimulation.
OUTCOME MEASURES Measurements of laryngeal symptomatology will be measured over a run-in period and during challenge testing. Laryngeal relaxation will be studied using our novel tracking software capability, combining endoscopic imaging and physiological measurements of diaphragm activation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in laryngeal relaxation time (seconds) during challenge testing
时间窗: At baseline and immediately after challenge testing
Change in time for glottic angle to normalise (i.e. achieve a value equal to or above the value prior to sensory stimulus)
Maximal decrease in glottic anterior angle (degrees) during challenge testing
时间窗: Baseline measurement is taken immediately before beginning the challenge test. Minimal value is taken from continuously measured glottic anterior angle, from immediately after baseline measurement and until immediately after challenge testing
The maximal decrease in glottic anterior angle during challenge testing
Maximal increase in glottic anterior angle (degrees) after challenge testing
时间窗: During challenge testing and from immediately after challenge testing until 5 minutes after challenge testing
The difference between the minimal glottic anterior angle observed during challenge testing and the maximal glottic anterior angle observed from immediately after challenge testing and until 5 minutes after challenge testing
Maximal laryngeal relaxation time (seconds)
时间窗: At baseline, during challenge testing and from immediately after challenge testing until 5 minutes after challenge testing
Maximum time for glottic angle to normalise (i.e. achieve a value equal to or above the value prior to sensory stimulus)
Change in laryngeal relaxation time (seconds) in recovery
时间窗: Immediately after challenge testing and at 5 minutes after challenge testing
Change in time for glottic angle to normalise (i.e. achieve a value equal to or above the value prior to sensory stimulus)
次要结局
- Cough VAS (0-100 mm)(At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing)
- Cough count and frequency(At baseline, during challenge testing at minutes 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30 and 4:00 (from immediately after an administered dose of ATP and until 15 seconds after an administered dose) and immediately after challenge testing)
研究者
Emil Walsted
Principal Investigator
Bispebjerg Hospital