Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-10-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Inferior Nasal Turbinate Hypertrophy Extraesophageal Reflux

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No masking is being used in this study

Study Groups

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1st degree of hypertrophy according to Camacho

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.

Group Type EXPERIMENTAL