Inferior Nasal Turbinate HypertrophyNCT04581174

Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy

A study testing 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated in people with Inferior Nasal Turbinate Hypertrophy and Extraesophageal Reflux, run by University Hospital Ostrava at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Inferior Nasal Turbinate Hypertrophy, Extraesophageal Reflux
What is being tested?: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 3 sitesin 2 countries
Study dates: 15 Oct 2020to 30 Oct 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Czechia2 sites

University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Fortmedica Prague
Prague, 14300

Other trials in Czechia

Slovakia1 site

Comenius University, University Hospital Bratislava
Bratislava, 85107

Other trials in Slovakia

About this study

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

Read the 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

Conditions: Inferior Nasal Turbinate Hypertrophy, Extraesophageal Reflux
Being tested: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated
Keywords: Inferior nasal turbinate hypertrophy, Extraesophageal reflux, Oropharyngeal pH monitoring, Restech system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluatedDiagnostic test
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.

Study groups in NCT04581174
Study group	Role	What they receive
1st degree of hypertrophy according to Camacho	Experimental	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. Receives: Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated
2nd degree of hypertrophy according to Camacho	Experimental	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. Receives: Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated
3rd degree of hypertrophy according to Camacho	Experimental	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. Receives: Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated
4th degree of hypertrophy according to Camacho	Experimental	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. Receives: Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202030 Oct 2021

First posted9 Oct 2020
Study start15 Oct 2020
Primary completion30 Sep 2021
Study completion30 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Inferior Nasal Turbinate HypertrophyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
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)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04581174
Sponsor's protocol ID: FNO-ENT-turbinates_hypertrophy
Status last verified: Dec 2022
First submitted: 2 Oct 2020
Last updated: 7 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data may be made available to other researchers upon request.

Publications

Camacho M, Zaghi S, Certal V, Abdullatif J, Means C, Acevedo J, Liu S, Brietzke SE, Kushida CA, Capasso R. Inferior turbinate classification system, grades 1 to 4: development and validation study. Laryngoscope. 2015 Feb;125(2):296-302. doi: 10.1002/lary.24923. Epub 2014 Sep 12.
PubMed 25215619
Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8.
PubMed 17216738
Camacho M, Zaghi S, Certal V, Abdullatif J, Modi R, Sridhara S, Tolisano AM, Chang ET, Cable BB, Capasso R. Predictors of Nasal Obstruction: Quantification and Assessment Using Multiple Grading Scales. Plast Surg Int. 2016;2016:6945297. doi: 10.1155/2016/6945297. Epub 2016 May 16.
PubMed 27293885
Ayazi S, Lipham JC, Hagen JA, Tang AL, Zehetner J, Leers JM, Oezcelik A, Abate E, Banki F, DeMeester SR, DeMeester TR. A new technique for measurement of pharyngeal pH: normal values and discriminating pH threshold. J Gastrointest Surg. 2009 Aug;13(8):1422-9. doi: 10.1007/s11605-009-0915-6. Epub 2009 May 7.
PubMed 19421822
Chheda NN, Seybt MW, Schade RR, Postma GN. Normal values for pharyngeal pH monitoring. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):166-71. doi: 10.1177/000348940911800302.
PubMed 19374146
Wiener GJ, Tsukashima R, Kelly C, Wolf E, Schmeltzer M, Bankert C, Fisk L, Vaezi M. Oropharyngeal pH monitoring for the detection of liquid and aerosolized supraesophageal gastric reflux. J Voice. 2009 Jul;23(4):498-504. doi: 10.1016/j.jvoice.2007.12.005. Epub 2008 May 12.
PubMed 18468849
Zelenik K, Matousek P, Formanek M, Urban O, Kominek P. Patients with chronic rhinosinusitis and simultaneous bronchial asthma suffer from significant extraesophageal reflux. Int Forum Allergy Rhinol. 2015 Oct;5(10):944-9. doi: 10.1002/alr.21560. Epub 2015 Jun 5.
PubMed 26046448

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Nasal Obstruction Due to Inferior Turbinate Hypertrophy
Not yet recruiting
Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
Deviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
Recruiting
Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid
Allergic Rhinitis
Active, not recruiting
Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic Rhinitis
Nasal Obstruction, Chronic Rhinitis
Recruiting
Efficacy of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures
Inferior Turbinate Hypertrophy, Chronic Rhinosinusitis (CRS)

All Inferior Nasal Turbinate Hypertrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy
ClinicalTrials.gov ID: NCT04581174
Acronym / sponsor ID: FNO-ENT-turbinates_hypertrophy
Conditions: Inferior Nasal Turbinate Hypertrophy, Extraesophageal Reflux
Keywords: Inferior nasal turbinate hypertrophy, Extraesophageal reflux, Oropharyngeal pH monitoring, Restech system
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: University Hospital OstravaUniversity, hospital or other
Collaborators: University Hospital Bratislava, Fortmedica Prague
Study start: 15 Oct 2020 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 30 Oct 2021 (actual)
First posted: 9 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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 design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
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)

Arm	Type	Receives
1st degree of hypertrophy according to Camacho	Experimental	Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluatedPatients 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.
2nd degree of hypertrophy according to Camacho	Experimental	Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluatedPatients 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.
3rd degree of hypertrophy according to Camacho	Experimental	Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluatedPatients 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.
4th degree of hypertrophy according to Camacho	Experimental	Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluatedPatients 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluatedPatients 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.	Diagnostic test	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

Primary outcome

Severity of extraesophageal reflux using oropharyngeal pH monitoring
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
Background: PubMed 25215619Camacho M, Zaghi S, Certal V, Abdullatif J, Means C, Acevedo J, Liu S, Brietzke SE, Kushida CA, Capasso R. Inferior turbinate classification system, grades 1 to 4: development and validation study. Laryngoscope. 2015 Feb;125(2):296-302. doi: 10.1002/lary.24923. Epub 2014 Sep 12.
Background: PubMed 17216738Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8.
Background: PubMed 27293885Camacho M, Zaghi S, Certal V, Abdullatif J, Modi R, Sridhara S, Tolisano AM, Chang ET, Cable BB, Capasso R. Predictors of Nasal Obstruction: Quantification and Assessment Using Multiple Grading Scales. Plast Surg Int. 2016;2016:6945297. doi: 10.1155/2016/6945297. Epub 2016 May 16.
Background: PubMed 19421822Ayazi S, Lipham JC, Hagen JA, Tang AL, Zehetner J, Leers JM, Oezcelik A, Abate E, Banki F, DeMeester SR, DeMeester TR. A new technique for measurement of pharyngeal pH: normal values and discriminating pH threshold. J Gastrointest Surg. 2009 Aug;13(8):1422-9. doi: 10.1007/s11605-009-0915-6. Epub 2009 May 7.
Background: PubMed 19374146Chheda NN, Seybt MW, Schade RR, Postma GN. Normal values for pharyngeal pH monitoring. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):166-71. doi: 10.1177/000348940911800302.
Background: PubMed 18468849Wiener GJ, Tsukashima R, Kelly C, Wolf E, Schmeltzer M, Bankert C, Fisk L, Vaezi M. Oropharyngeal pH monitoring for the detection of liquid and aerosolized supraesophageal gastric reflux. J Voice. 2009 Jul;23(4):498-504. doi: 10.1016/j.jvoice.2007.12.005. Epub 2008 May 12.
Background: PubMed 26046448Zelenik K, Matousek P, Formanek M, Urban O, Kominek P. Patients with chronic rhinosinusitis and simultaneous bronchial asthma suffer from significant extraesophageal reflux. Int Forum Allergy Rhinol. 2015 Oct;5(10):944-9. doi: 10.1002/alr.21560. Epub 2015 Jun 5.
Individual participant dataSharing planned: No. Individual participant data may be made available to other researchers upon request.

Related trials for Inferior Nasal Turbinate Hypertrophy

Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Nasal Obstruction Due to Inferior Turbinate Hypertrophy
Not yet recruiting
Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
Deviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
Recruiting
Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid
Allergic Rhinitis
Active, not recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karol Zeleník, Ass.Prof.,MD,PhD principal investigator

University Hospital Ostrava

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Czechia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of extraesophageal reflux using oropharyngeal pH monitoring (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04581174, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.