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Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy

Primary Purpose

Inferior Nasal Turbinate Hypertrophy, Extraesophageal Reflux

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inferior Nasal Turbinate Hypertrophy focused on measuring Inferior nasal turbinate hypertrophy, Extraesophageal reflux, Oropharyngeal pH monitoring, Restech system

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18-80 years
  • patients indicated for oropharyngeal pH-metry (Restech) with suspected extraesophageal reflux
  • patients with 2nd - 4th degree hypertrophy of the lower turbinates (according to Camacho Classification)

Exclusion Criteria:

  • patients with chronic rhinosinusitis with polyps
  • patients who have had an acute upper respiratory tract infection in the last 8 weeks
  • patients after previous surgery in the nasal cavity and nasopharynx
  • patients after radiotherapy in the head and neck area
  • non tolerance of pH catheter

Sites / Locations

  • University Hospital Ostrava
  • Fortmedica Prague
  • Comenius University, University Hospital Bratislava

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2020
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
Collaborators
University Hospital Bratislava, Fortmedica Prague
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1. Study Identification

Unique Protocol Identification Number
NCT04581174
Brief Title
Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy
Official Title
Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
University Hospital Bratislava, Fortmedica Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study examines the severity of extraesophageal reflux using oropharyngeal pH monitoring in patients with varying degrees of lower turbinates hypertrophy.
Detailed Description
Hypertrophy of the lower turbinates causes obstruction of the nasal breathing with several health risks and a significant reduction in quality of life. Mouth breathing is non-physiological. When breathing through the mouth, the air is not purified, warmed, or humidified. This results in more frequent respiratory infections, drying of the airways, burning in the throat and causes snoring and sleep apnoea overnight. Also, nasal obstruction leads to a significant reduction in quality of life. Conservative treatment with topically applied corticosteroids is often without effect and surgical reduction of the lower turbinates under local or general anesthesia is necessary. The operation is another discomfort for the patient and is not without risks. The pathogenesis of lower turbinates hypertrophy is multifactorial. Currently, extraesophageal reflux (EER) is considered to be a possible factor as well. The role of EER in chronic rhinosinusitis, especially in difficult-to-treat conditions, has been investigated in the past, and EER would likely be a possible co-factor. The relationship between hypertrophic lower turbinates and EER has not been studied yet. The primary outcome/goal of the study: To examine the severity of extraesophageal reflux using oropharyngeal pH monitoring in patients with varying degrees of lower turbinates hypertrophy. Other goals: To compare extraesophageal reflux severity in patients with posterior inferior turbinate hypertrophy. To evaluate the difference between anterior and posterior hypertrophy of the inferior turbinates in patients with proven extraesophageal reflux. To evaluate the lateral difference of lower turbinates hypertrophy in patients with proven EER and in patients without proven EER. Study protocol: anamnestic questionnaire (age, sex, weight, height, smoking, alcohol, reflux disease, treatment with topical corticosteroids, treatment of reflux disease) Reflux Symptom Index (RSI) questionnaire Sino-Nasal Outcome Test (SNOT 22) questionnaire rhinomanometry (optional - if available) acoustic rhinometry (optional - if available) olfactory questionnaire (optional - if available) endoscopy of the nasal cavity with evaluation: of the degree of hypertrophy of the lower turbinates according to Camacho, 2014 (for both turbinates separately and separately anterior and posterior half of the turbinates) (attachment 1) of bulky posterior inferior turbinate hypertrophy of reddening of the posterior ends of the lower turbinates of reddening of nasopharynx 24-hour monitoring of oropharyngeal pH by Restech, RYAN score upright and supine and pH values <5.5 will be evaluated

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inferior Nasal Turbinate Hypertrophy, Extraesophageal Reflux
Keywords
Inferior nasal turbinate hypertrophy, Extraesophageal reflux, Oropharyngeal pH monitoring, Restech system

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study subjects will be enrolled to a total of four study arms, depending on the degree of inferior turbinates hypertrophy (according to Camacho)
Masking
None (Open Label)
Masking Description
No masking is being used in this study
Allocation
Non-Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1st degree of hypertrophy according to Camacho
Arm Type
Experimental
Arm Description
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.
Arm Title
2nd degree of hypertrophy according to Camacho
Arm Type
Experimental
Arm Description
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.
Arm Title
3rd degree of hypertrophy according to Camacho
Arm Type
Experimental
Arm Description
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.
Arm Title
4th degree of hypertrophy according to Camacho
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of extraesophageal reflux using oropharyngeal pH monitoring
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18-80 years patients indicated for oropharyngeal pH-metry (Restech) with suspected extraesophageal reflux patients with 2nd - 4th degree hypertrophy of the lower turbinates (according to Camacho Classification) Exclusion Criteria: patients with chronic rhinosinusitis with polyps patients who have had an acute upper respiratory tract infection in the last 8 weeks patients after previous surgery in the nasal cavity and nasopharynx patients after radiotherapy in the head and neck area non tolerance of pH catheter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karol Zeleník, Ass.Prof.,MD,PhD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Fortmedica Prague
City
Praha
ZIP/Postal Code
14300
Country
Czechia
Facility Name
Comenius University, University Hospital Bratislava
City
Bratislava
ZIP/Postal Code
85107
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data may be made available to other researchers upon request.
Citations:
PubMed Identifier
25215619
Citation
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.
Results Reference
background
PubMed Identifier
17216738
Citation
Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8.
Results Reference
background
PubMed Identifier
27293885
Citation
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.
Results Reference
background
PubMed Identifier
19421822
Citation
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.
Results Reference
background
PubMed Identifier
19374146
Citation
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.
Results Reference
background
PubMed Identifier
18468849
Citation
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.
Results Reference
background
PubMed Identifier
26046448
Citation
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.
Results Reference
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Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy

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