Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy

Not Applicable

Completed

• Conditions: Extraesophageal Reflux; Inferior Nasal Turbinate Hypertrophy

• Registration Number: NCT04581174
• Lead Sponsor: University Hospital Ostrava

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

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-09
• Study Start: 2020-10-15
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severity of extraesophageal reflux using oropharyngeal pH monitoring	24 hours	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.

Trial Locations

Locations (3)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia

Fortmedica Prague; 🇨🇿 Praha, Czechia

Comenius University, University Hospital Bratislava; 🇸🇰 Bratislava, Slovakia