Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy
Condition: Inferior Nasal Turbinate Hypertrophy; Extraesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Hypertrophy
Study type: Interventional

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
    

Intervention name(s): 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated
Intervention type(s): Diagnostic Test
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
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)
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Inferior nasal turbinate hypertrophy; Extraesophageal reflux; Oropharyngeal pH monitoring; Restech system