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NCT Number: NCT07365046

Comprehensive Analysis of the Swallowing Mechanism Using High-resolution Manometry With Impedance

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location contact

Dominik Tichý, MD

PRINCIPAL_INVESTIGATOR

Jiří Hynčica

CONTACT

[email protected]

+42059737 ext. 2587

Karol Zeleník, prof., MD, PhD, MBA

SUB_INVESTIGATOR

Patrícia Gubová, MD

SUB_INVESTIGATOR

Viktória Hránková, MD, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High resolution oesophageal manometry with impedance

Diagnostic Test

Patients with extraoesophageal reflux and dysphagia will undergo high resolution oesophageal manometry with impedance.

24-hour pH metry

Diagnostic Test

Patients with extraoesophageal reflux will undergo 24-hour pH-metry.

Primary outcomes

  1. PAET (Proximal Acid Exposure Time)

    Time frame: 24 hours

    PAET (Proximal Acid Exposure Time) - acid exposure to the proximal oesophageus will be measured in per cent of the whole 24-h period.

  2. Upper esophageal sphincter (UES) Integrated Relaxation Pressure (IRP)

    Time frame: 15 minutes

    UES IRP is a measure of the extent of UES relaxation measured in mmHg

  3. UES Maximum Admittance

    Time frame: 15 minutes

    UES MaxAd is the highest admittance value recorded during trans-sphincteric bolus flow measured in milliseconds.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

+42059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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