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The Diagnostics of Extraesophageal Reflux With the Restech System

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital Ostrava
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01819454
First received: March 22, 2013
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

The aim of the project is to define the frequency with which EER is present in patient with chronic rhinosinusitis (CHR). The measurement will be carried out with a 24-hour monitoring of the pH using the Restech system. This modern device is equipped with a narrow antimony probe. The sensor is able to record not only liquid but also aerosol reflux episodes. The second aim is to determine the relation among EER, CHR and asthma bronchiale. We will compare the presence of reflux in three different patient groups (1. CHR without nasal polyposis, without asthma bronchiale or ASA syndrome, 2. CHR with nasal polyposis, without asthma bronchiale or ASA syndrome, 3. CHR with nasal polyposis and asthma bronchiale and/or ASA syndrome). We expect to find a significantly more frequent presence of EER in patients with CHR and asthma bronchiale or ASA syndrome. In case our hypothesis is confirmed, it will be especially these patients(with a difficult to manage nasal polyposis) benefiting from the antireflux therapy.


Condition Intervention
Nasal Diseases
Nasal Polyps
Laryngopharyngeal Reflux
Device: pH monitoring (Restech)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Diagnostics of Extraesophageal Reflux With the Restech System in Patients With Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by University Hospital Ostrava:

Primary Outcome Measures:
  • The frequency of the extraesophageal reflux in patients with chronic rhinosisnusitis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    EER will be measured using RYAN score, number of episodes and time of pH below 5.5


Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pH monitoring sinusitis no polyps
30 patients with chronic rhinosinusitis without nasal polyposis, without asthma bronchiale or ASA syndrome
Device: pH monitoring (Restech)
see in "detail description of the study" part of the protocol
Other Name: oropharyngeal pH monitoring using Restech system
Experimental: pH monitoring sinusitis with polyp
30 patients with chronic rhinosinusitis with nasal polyposis, without asthma bronchiale or ASA syndrome
Device: pH monitoring (Restech)
see in "detail description of the study" part of the protocol
Other Name: oropharyngeal pH monitoring using Restech system
Experimental: pH monitoring sinusitis, polyps, asthma
30 patients with chronic rhinosinusitis with nasal polyposis and with asthma bronchiale and/or ASA syndrome
Device: pH monitoring (Restech)
see in "detail description of the study" part of the protocol
Other Name: oropharyngeal pH monitoring using Restech system

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signing of the informed consent
  • patients with chronic rhinosinusitis

Exclusion Criteria:

-non-tolerance of the pH catheter

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819454

Contacts
Contact: Karol Zelenik, MD,PhD 0042059737 ext 5816 karol.zelenik@fno.cz
Contact: Pavel Kominek, MD,PhD,MBA 0042059737 ext 5801 pavel.kominek@fno.cz

Locations
Czech Republic
University Hospital Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czech Republic, 70800
Contact: Vaclav Prochazka, MD,PhD,MSc    0042059737 ext 2544    vaclav.prochazka@fno.cz   
Contact: Katerina Vitkova, RNDr    0042059737 ext 2511    katerina.vitkova@fno.cz   
Principal Investigator: Karol Zelenik, MD,PhD         
Sponsors and Collaborators
University Hospital Ostrava
Investigators
Principal Investigator: Karol Zelenik, MD,PhD University Hospital Ostrava
  More Information

Publications:
Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01819454     History of Changes
Other Study ID Numbers: FNO-ENT-EER Restech, NT13500-4/2012
Study First Received: March 22, 2013
Last Updated: February 5, 2014
Health Authority: Czech Republic: Ethics Committee

Keywords provided by University Hospital Ostrava:
chronic rhinosinusitis
extraesophageal reflux
Restech system
antireflux therapy

Additional relevant MeSH terms:
Nose Diseases
Gastroesophageal Reflux
Nasal Polyps
Regurgitation, Gastric
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2014