Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04581174
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2020-10-02
Brief Title:
Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy
Sponsor:
University Hospital Ostrava
Organization:
University Hospital Ostrava
Study Overview
Official Title:
Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 outcomegoal 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 55 will be evaluated
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 outcomegoal 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 55 will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None