| Registry | NCT07365046 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, diagnostic |
| Enrollment | 160 (Estimated) |
| Sponsor | University Hospital Ostrava (Other) |
| Conditions | Extraesophageal Reflux, Laryngopharyngeal Reflux, Dysphagia, Chronic Cough |
| Interventions | High resolution oesophageal manometry with impedance, 24-hour pH metry (Diagnostic test) |
| Dates | start 2026-01-01 (estimated), primary completion 2028-06-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-01-23, last updated 2026-01-23 |
| Locations | 1 site in Czechia |
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All trials for Extraesophageal Reflux All trials for Laryngopharyngeal Reflux All trials of High resolution oesophageal manometry with impedance All trials of 24-hour pH metry
The aim of this project is to perform a detailed evaluation of upper esophageal sphincter function and the swallowing mechanism in patients with swallowing disorders or suspected extraesophageal reflux using high-resolution manometry with impedance and 24-hour pH-impedance monitoring.
The project seeks to improve diagnostic accuracy, identify functional abnormalities that are not detectable by conventional diagnostic methods, and establish a foundation for more effective and targeted therapeutic strategies.
The upper esophageal sphincter (UES) represents a crucial functional structure at the junction of the digestive and respiratory tracts. Its proper function is essential for the coordination of the swallowing process and for the protection of the upper airways. Disorders of the UES may be associated with a wide range of otorhinolaryngological symptoms, including dysphagia, globus pharyngeus, chronic cough, hoarseness, laryngeal dysfunction, and voice disorders. Modern diagnostic techniques, such as 24-hour esophageal impedance monitoring and high-resolution manometry (HRM), enable detailed assessment of gastroesophageal reflux and esophageal pressure dynamics, thereby offering new possibilities for the diagnosis and understanding of these conditions.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Extraoesophageal reflux | Experimental | Diagnostic Test: High resolution oesophageal manometry with impedance; Diagnostic Test: 24-hour pH metry | Patients with extraoesophageal reflux will be enrolled in this study arm. |
| Dysphagia | Experimental | Diagnostic Test: High resolution oesophageal manometry with impedance | Patients with dysphagia reflux will be enrolled in this study arm. |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: * age 18-75 years * patients with swallowing difficulties suspected of having a functional oesophageal disorder or patients with clinical signs of extra-oesophageal reflux (Reflux Symptom Index \[RSI\] ≥ 13 or Reflux Symptom Score-12 \[RSS-12\] ≥ 11) signed informed consent Exclusion Criteria: * patients with a diagnosed tumor of the esophagus or upper airway, or with strong clinical suspicion of a tumor of the esophagus or upper airway * severe neurological disease affecting swallowing * pregnancy * surgery involving the head, neck, or esophagus within the last 6 months
| Facility | City | Country | Status |
|---|---|---|---|
| University Hospital Ostrava | Ostrava, Moravian-Silesian Region | Czechia |