NCT07365046

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

Study Start

First participant enrolled

January 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Extraesophageal RefluxLaryngopharyngeal RefluxDysphagiaChronic Cough

Keywords

Extraesophageal refluxLaryngopharyngeal refluxDysphagiaChronic coughhigh-resolution manometry24-hour pH-impedance monitoring

Outcome Measures

Primary Outcomes (3)

  • 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.

    24 hours

  • Upper esophageal sphincter (UES) Integrated Relaxation Pressure (IRP)

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

    15 minutes

  • UES Maximum Admittance

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

    15 minutes

Study Arms (2)

Extraoesophageal reflux

EXPERIMENTAL

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

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

Dysphagia

EXPERIMENTAL

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

Diagnostic Test: High resolution oesophageal manometry with impedance

Interventions

High resolution oesophageal manometry with impedanceDIAGNOSTIC_TEST

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

DysphagiaExtraoesophageal reflux
24-hour pH metryDIAGNOSTIC_TEST

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

Extraoesophageal reflux

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (5)

  • 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. 2025 Apr 9:e70042. doi: 10.1111/nmo.70042. Online ahead of print.

    PMID: 40202098BACKGROUND

  • 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.

    PMID: 36121685BACKGROUND

  • 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.

    PMID: 39779205BACKGROUND

  • 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.

    PMID: 39102762BACKGROUND

  • 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.

    PMID: 34366184BACKGROUND

MeSH Terms

Conditions

Laryngopharyngeal RefluxDeglutition DisordersChronic Cough

Interventions

Electric Impedance

Condition Hierarchy (Ancestors)

Gastroesophageal RefluxEsophageal Motility DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLaryngeal DiseasesRespiratory Tract DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCoughRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric ConductivityElectricityElectromagnetic PhenomenaMagnetic PhenomenaPhysical Phenomena

Study Officials

  • Dominik Tichý, MD

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

+42059737jiri.hyncica@fno.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking will be used in the study.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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

Locations

CZ(1)