Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy

Study Overview
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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.

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

Official Title
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Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy

Conditions
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Inferior Nasal Turbinate Hypertrophy, Extraesophageal Reflux

Intervention / Treatment
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* Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1st degree of hypertrophy according to Camacho<br>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. | Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated<br>* 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.<br>|
| Experimental: 2nd degree of hypertrophy according to Camacho<br>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. | Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated<br>* 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.<br>|
| Experimental: 3rd degree of hypertrophy according to Camacho<br>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. | Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated<br>* 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.<br>|
| Experimental: 4th degree of hypertrophy according to Camacho<br>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. | Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inferior nasal turbinate hypertrophy, Extraesophageal reflux, Oropharyngeal pH monitoring, Restech system