NCT04581174|Completed
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Sponsor study identifier
interventional
160
2 countries
3
Study Start
October 15, 2020
Actual (reported)Primary Completion
September 30, 2021
Actual (reported)Study Completion
October 30, 2021
Actual (reported)The study examines the severity of extraesophageal reflux using oropharyngeal pH monitoring in patients with varying degrees of lower turbinates hypertrophy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2, 2020
Actual (reported)October 9, 2020
Actual (reported)October 15, 2020
Actual (reported)September 30, 2021
Actual (reported)October 30, 2021
Actual (reported)Severity of extraesophageal reflux using oropharyngeal pH monitoring
The primary outcome measure of the study is to examine the severity of extraesophageal reflux using oropharyngeal pH monitoring in patients with varying degrees of lower turbinates hypertrophy, assessed on the RYAN score.
24 hours
Patients with 1st degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values \<5.5 will be evaluated.
Patients with 2nd degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values \<5.5 will be evaluated.
Patients with the 1st degree of hypertrophy according to Camacho, 2nd degree of hypertrophy according to Camacho, 3rd degree of hypertrophy according to Camacho, 4th degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values \<5.5 will be evaluated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852, Czechia
Fortmedica Prague
Prague, 14300, Czechia
Comenius University, University Hospital Bratislava
Bratislava, 85107, Slovakia
Camacho M, Zaghi S, Certal V, Abdullatif J, Means C, Acevedo J, Liu S, Brietzke SE, Kushida CA, Capasso R. Inferior turbinate classification system, grades 1 to 4: development and validation study. Laryngoscope. 2015 Feb;125(2):296-302. doi: 10.1002/lary.24923. Epub 2014 Sep 12.
Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8.
Karol Zeleník, Ass.Prof.,MD,PhD
University Hospital Ostrava
160 participants (actual enrollment reported by the registry).
First Submitted
October 2, 2020
First Posted
October 9, 2020
Study Start
October 15, 2020
Patients with 3rd degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values \<5.5 will be evaluated.
Patients with 4th degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values \<5.5 will be evaluated.
Contact the study team to confirm eligibility.
Camacho M, Zaghi S, Certal V, Abdullatif J, Modi R, Sridhara S, Tolisano AM, Chang ET, Cable BB, Capasso R. Predictors of Nasal Obstruction: Quantification and Assessment Using Multiple Grading Scales. Plast Surg Int. 2016;2016:6945297. doi: 10.1155/2016/6945297. Epub 2016 May 16.
Ayazi S, Lipham JC, Hagen JA, Tang AL, Zehetner J, Leers JM, Oezcelik A, Abate E, Banki F, DeMeester SR, DeMeester TR. A new technique for measurement of pharyngeal pH: normal values and discriminating pH threshold. J Gastrointest Surg. 2009 Aug;13(8):1422-9. doi: 10.1007/s11605-009-0915-6. Epub 2009 May 7.
Chheda NN, Seybt MW, Schade RR, Postma GN. Normal values for pharyngeal pH monitoring. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):166-71. doi: 10.1177/000348940911800302.
Wiener GJ, Tsukashima R, Kelly C, Wolf E, Schmeltzer M, Bankert C, Fisk L, Vaezi M. Oropharyngeal pH monitoring for the detection of liquid and aerosolized supraesophageal gastric reflux. J Voice. 2009 Jul;23(4):498-504. doi: 10.1016/j.jvoice.2007.12.005. Epub 2008 May 12.
Zelenik K, Matousek P, Formanek M, Urban O, Kominek P. Patients with chronic rhinosinusitis and simultaneous bronchial asthma suffer from significant extraesophageal reflux. Int Forum Allergy Rhinol. 2015 Oct;5(10):944-9. doi: 10.1002/alr.21560. Epub 2015 Jun 5.
Primary Completion
September 30, 2021
Actual (reported)Study Completion
October 30, 2021
Actual (reported)Last Updated
December 7, 2022
Record last verified: 2022-12
Individual participant data may be made available to other researchers upon request.
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Source: ClinicalTrials.gov.
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