Clinical trial NCT04581174: Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy
Official title: Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inferior Nasal Turbinate Hypertrophy
Extraesophageal Reflux
Keywords: Inferior nasal turbinate hypertrophy
Extraesophageal reflux
Oropharyngeal pH monitoring
Restech system
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University Hospital Bratislava
name: Fortmedica Prague
First posted: 2020-10-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Severity of extraesophageal reflux using oropharyngeal pH monitoring
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
city: Praha
country: Czechia
facility: Fortmedica Prague
city: Bratislava
country: Slovakia
facility: Comenius University, University Hospital Bratislava
Study officials:
affiliation: University Hospital Ostrava
name: Karol Zeleník, Ass.Prof.,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8.
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.
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.
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.
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.
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.