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Not yet recruitingNCT07365046Updated Jan 23, 2026

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

An interventional study of High resolution oesophageal manometry with impedance and 24-hour pH metry in Extraesophageal Reflux, Laryngopharyngeal Reflux and Dysphagia, sponsored by University Hospital Ostrava. Not yet recruiting at 1 site in Czechia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Extraesophageal Reflux
  • Laryngopharyngeal Reflux
  • Dysphagia
  • Chronic Cough

Keywords

  • Extraesophageal reflux
  • Laryngopharyngeal reflux
  • Dysphagia
  • Chronic cough
  • high-resolution manometry
  • 24-hour pH-impedance monitoring
03

In context

Laryngopharyngeal Reflux

56 studies on the registry are indexed under Laryngopharyngeal Reflux; 8 are open to participants now.

This study's planned enrollment of 160 is above the median of 72 across 41 interventional studies indexed under Laryngopharyngeal Reflux.

Browse Laryngopharyngeal Reflux studies →

Lead sponsor

University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Extraoesophageal reflux

    Patients with extraoesophageal reflux will be enrolled in this study arm.

    Diagnostic Test: High resolution oesophageal manometry with impedance · Diagnostic Test: 24-hour pH metry

  • Experimental
    Dysphagia

    Patients with dysphagia reflux will be enrolled in this study arm.

    Diagnostic Test: High resolution oesophageal manometry with impedance

Interventions

  • Diagnostic testHigh resolution oesophageal manometry with impedance

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

  • Diagnostic test24-hour pH metry

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

06

What researchers measure

Primary outcomes

  1. PAET (Proximal Acid Exposure Time)

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

    Time frame: 24 hours

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

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

    Time frame: 15 minutes

  3. UES Maximum Admittance

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

    Time frame: 15 minutes

07

Study locations

1 site
  • University Hospital Ostrava
    Ostrava, Moravian-Silesian Region 70852, Czechia
    • Jiří Hynčica · Contactjiri.hyncica@fno.cz · +42059737
    • Dominik Tichý, MD · Principal investigator
    • Karol Zeleník, prof., MD, PhD, MBA · Sub investigator
    • Viktória Hránková, MD, PhD · Sub investigator
    • Patrícia Gubová, MD · Sub investigator
08

References and documents

Publications

  • Omari TI, Maclean JCF, Cock C, McCulloch TM, Nativ-Zeltzer N, O'Rourke AK, Szczesniak MM, Wu PI, Allen J, Aoyagi Y, Bayona HHG, Carrion S, Ciucci MR, Davidson K, Dhar SI, Hamdy S, Howell R, Jones C, Knigge MA, Moonen A, Postma GN, Puntil-Sheltman J, Rameau A, Regan J, Schar M, Rommel N. Defining Pharyngeal and Upper Esophageal Sphincter Disorders on High-Resolution Manometry-Impedance: The Leuven Consensus. Neurogastroenterol Motil. 2026 Apr;38(4):e70042. doi: 10.1111/nmo.70042. Epub 2025 Apr 9. PubMed 40202098 ↗
  • Omari T, Cock C, Wu P, Szczesniak MM, Schar M, Tack J, Rommel N. Using high resolution manometry impedance to diagnose upper esophageal sphincter and pharyngeal motor disorders. Neurogastroenterol Motil. 2023 Jan;35(1):e14461. doi: 10.1111/nmo.14461. Epub 2022 Sep 19. PubMed 36121685 ↗
  • Wang YC, Wang CC, Chuang CY, Tsou YA, Peng YC, Chang CS, Lien HC. Baseline Impedance via Manometry Predicts Pathological Mean Nocturnal Baseline Impedance in Isolated Laryngopharyngeal Reflux Symptoms. J Neurogastroenterol Motil. 2025 Jan 31;31(1):63-74. doi: 10.5056/jnm24051. PubMed 39779205 ↗
  • Watson W, Simmons E, Adebowale A, Banda C, Qu R, Becerra B, Crawley B, Murry T, Krishna P. Manometric Abnormalities in Patients With and Without Chronic Cough. Am J Otolaryngol. 2024 Nov-Dec;45(6):104445. doi: 10.1016/j.amjoto.2024.104445. Epub 2024 Jul 31. PubMed 39102762 ↗
  • Tseng WH, Hsu WC, Hsiao TY, Wu JF, Lee HC, Wang HP, Wu MS, Tseng PH. Anatomical and physiological characteristics in patients with Laryngopharyngeal Reflux Symptoms: A case-control study utilizing high-resolution impedance manometry. J Formos Med Assoc. 2022 Jun;121(6):1034-1043. doi: 10.1016/j.jfma.2021.07.025. Epub 2021 Aug 6. PubMed 34366184 ↗

Individual participant data

Plan to share: No — There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07365046
Responsible party
Sponsor
First posted
Jan 23, 2026
Start date
Jan 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 23, 2026

Study contacts

Jiří Hynčica
Contact
jiri.hyncica@fno.cz
+42059737 ext. 2587
Dominik Tichý, MD
principal investigator · University Hospital Ostrava

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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