A Comprehensive Evaluation of the Impact of ATP on Laryngeal Symptoms, Hypersensitivity and Function
- Conditions
- Chronic Refractory Cough
- Interventions
- Diagnostic Test: Laryngeal sensitivity testing
- Registration Number
- NCT05570981
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic Refractory Cough (CRC) Laryngeal sensitivity testing Individuals with a diagnosis of chronic refractory cough Healthy controls Laryngeal sensitivity testing Healthy control subjects matched to the CRC group by age and gender
- Primary Outcome Measures
Name Time Method Change in laryngeal relaxation time (seconds) during challenge testing 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 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 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) 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 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)
- Secondary Outcome Measures
Name Time Method 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 This is a descriptive delineation of the ATP/Cough VAS dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
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 This is a descriptive delineation of the ATP/Cough count dose/response relationship. The measure is taken at multiple times (see Time Frame) and visualised graphically.
Trial Locations
- Locations (1)
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark