Extraesophageal RefluxNCT07365046
Comprehensive Analysis of the Swallowing Mechanism Using High-resolution Manometry With Impedance
A study testing High resolution oesophageal manometry with impedance and 24-hour pH metry in people with Extraesophageal Reflux and Laryngopharyngeal Reflux, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extraesophageal Reflux, Laryngopharyngeal Reflux, Dysphagia
- What is being tested?
- High resolution oesophageal manometry with impedance and 24-hour pH metry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, +42059737 ext. 2587, jiri.hyncica@fno.cz
Dominik Tichý, MD
About this study
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.
- Being tested
- High resolution oesophageal manometry with impedance, 24-hour pH metry
- Keywords
- Extraesophageal reflux, Laryngopharyngeal reflux, Dysphagia, Chronic cough, high-resolution manometry, 24-hour pH-impedance monitoring
- Medical subject headings
- Laryngopharyngeal Reflux, Deglutition Disorders, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution oesophageal manometry with impedanceDiagnostic test
Patients with extraoesophageal reflux and dysphagia will undergo high resolution oesophageal manometry with impedance.
24-hour pH metryDiagnostic test
Patients with extraoesophageal reflux will undergo 24-hour pH-metry.
| Study group | Role | What they receive |
|---|---|---|
| Extraoesophageal reflux | Experimental | Patients with extraoesophageal reflux will be enrolled in this study arm. Receives: Diagnostic Test: High resolution oesophageal manometry with impedance; Diagnostic Test: 24-hour pH metry |
| Dysphagia | Experimental | Patients with dysphagia reflux will be enrolled in this study arm. Receives: Diagnostic Test: High resolution oesophageal manometry with impedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Upper esophageal sphincter (UES) Integrated Relaxation Pressure (IRP)
UES IRP is a measure of the extent of UES relaxation measured in mmHg
Measured: 15 minutes
UES Maximum Admittance
UES MaxAd is the highest admittance value recorded during trans-sphincteric bolus flow measured in milliseconds.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Extraesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominik Tichý, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365046
- Sponsor's protocol ID
- FNO-ENT-Manometry
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
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 40202098Omari 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 36121685Wang 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 39779205Watson 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 39102762Tseng 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Analysis of the Swallowing Mechanism Using High-resolution Manometry With Impedance
- ClinicalTrials.gov ID
- NCT07365046
- Acronym / sponsor ID
- FNO-ENT-Manometry
- Keywords
- Extraesophageal reflux, Laryngopharyngeal reflux, Dysphagia, Chronic cough, high-resolution manometry, 24-hour pH-impedance monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extraoesophageal reflux | Experimental | Diagnostic Test: High resolution oesophageal manometry with impedance, Diagnostic Test: 24-hour pH metryPatients with extraoesophageal reflux will be enrolled in this study arm. |
| Dysphagia | Experimental | Diagnostic Test: High resolution oesophageal manometry with impedancePatients with dysphagia reflux will be enrolled in this study arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High resolution oesophageal manometry with impedancePatients with extraoesophageal reflux and dysphagia will undergo high resolution oesophageal manometry with impedance. | Diagnostic test | Dysphagia, Extraoesophageal reflux |
| 24-hour pH metryPatients with extraoesophageal reflux will undergo 24-hour pH-metry. | Diagnostic test | Extraoesophageal reflux |
Primary outcome
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.
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
UES Maximum Admittance
Time frame: 15 minutes
UES MaxAd is the highest admittance value recorded during trans-sphincteric bolus flow measured in milliseconds.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 40202098Omari 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.
- Background: PubMed 36121685Omari 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.
- Background: PubMed 39779205Wang 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.
- Background: PubMed 39102762Watson 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.
- Background: PubMed 34366184Tseng 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dominik Tichý, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resolution oesophageal manometry with impedance and 24-hour pH metry in people with Extraesophageal Reflux and Laryngopharyngeal Reflux, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (+42059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAET (Proximal Acid Exposure Time) (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07365046, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.