Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy

Extraesophageal Reflux Clinical Trial

Official title:

Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581174
• Other study ID #: FNO-ENT-turbinates_hypertrophy
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study examines the severity of extraesophageal reflux using oropharyngeal pH monitoring in patients with varying degrees of lower turbinates hypertrophy.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Extraesophageal Reflux
• Gastroesophageal Reflux
• Hypertrophy
• Inferior Nasal Turbinate Hypertrophy

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region
Czechia	Fortmedica Prague	Praha
Slovakia	Comenius University, University Hospital Bratislava	Bratislava

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Ostrava	Fortmedica Prague, University Hospital Bratislava

Countries where clinical trial is conducted

Czechia,  Slovakia, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View Citation

Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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