Empty Nose SyndromeNCT02230423
Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome
A study testing Nasal surgery in people with Empty Nose Syndrome, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study investigates wether patients with increased trigeminal perception threshold and low expression of TRP channels have more often nasal blockage despite functionally successful nasal surgery (TRP channel = transient receptor potential channel). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Empty Nose Syndrome
- What is being tested?
- Nasal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to May 2018
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing a primary septoplasty and/or turbinoplasty
- Patients suffering from empty nose syndrome after measurably successful nasal surgery
- Patients with removed turbinates and/or septum, not suffering from ENS (i.e. tumor patients)
Who cannot join
- Patients with known neurologic disorders that could compromise perception threshold measurements
- Patients with known allergies/intolerance to test agents that are used to measure perception thresholds (Cineol=Eucalypt; Menthol, CO2= Carbon Dioxide)
- Inability to judge or understand the testing or the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trigeminale Endonasale Perzeption, Ein Prädiktor für Das Outcome Einer Septumplastik - Eine Prospektive Kohortenstudie Mit Klinischen Und Biologischen Untersuchungen
This study investigates wether patients with increased trigeminal perception threshold and low expression of TRP channels have more often nasal blockage despite functionally successful nasal surgery (TRP channel = transient receptor potential channel).
Read the detailed description
The aim of this study is to find out wether patients with high trigeminal perception threshold (=decreased intranasal sensibility) and low expression of TRP channels of the mucosa suffer more often from impaired nasal breathing after surgery. This could lead to the identification of prognostic factors and therefore prevention of nasal surgery with bad outcome.
Further, differences between patients with empty nose syndrome and asymptomatic patients after extended intranasal surgery, concerning trigeminal perception and TRP channel expression will be investigated.
- Conditions
- Empty Nose Syndrome
- Being tested
- Nasal surgery
- Keywords
- Functional nasal surgery, Empty Nose Syndrome (ENS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal surgeryProcedure or surgery
Also called Septoplasty, Turbinoplasty, Removal of turbinates and septum parts
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving nose surgery | Experimental | Patients in need of nose surgery, before and after surgery; or only after successful surgery, then with or without "Empty Nose Syndrome". Receives: Procedure: Nasal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression
Measured: Up to 1 year post-surgery
Secondary outcomes (1)
Differences between trigeminal perception threshold as as well as TRP expression levels in patients with postoperative empty nose syndrome and patients with subjectively unimpaired nasal breathing after extended intranasal surgery
Measured: Up to 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startMay 2015
- Primary completionApr 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Empty Nose SyndromeStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Soyka, Dr.med., Principal investigator, Zurich University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230423
- Sponsor's protocol ID
- SM_31_01_2014
- Other IDs
- KEK-ZH-Nr: 2013-0545
- Status last verified
- Oct 2018
- First submitted
- 28 Apr 2014
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigeminale Endonasale Perzeption, Ein Prädiktor für Das Outcome Einer Septumplastik - Eine Prospektive Kohortenstudie Mit Klinischen Und Biologischen Untersuchungen
- ClinicalTrials.gov ID
- NCT02230423
- Acronym / sponsor ID
- SM_31_01_2014
- Conditions
- Empty Nose Syndrome
- Keywords
- Functional nasal surgery, Empty Nose Syndrome (ENS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Sep 2014 (estimated)
- 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.
This study investigates wether patients with increased trigeminal perception threshold and low expression of TRP channels have more often nasal blockage despite functionally successful nasal surgery (TRP channel = transient receptor potential channel).
Detailed description
The aim of this study is to find out wether patients with high trigeminal perception threshold (=decreased intranasal sensibility) and low expression of TRP channels of the mucosa suffer more often from impaired nasal breathing after surgery. This could lead to the identification of prognostic factors and therefore prevention of nasal surgery with bad outcome.
Further, differences between patients with empty nose syndrome and asymptomatic patients after extended intranasal surgery, concerning trigeminal perception and TRP channel expression will be investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving nose surgery | Experimental | Procedure: Nasal surgeryPatients in need of nose surgery, before and after surgery; or only after successful surgery, then with or without "Empty Nose Syndrome". |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing a primary septoplasty and/or turbinoplasty
- Patients suffering from empty nose syndrome after measurably successful nasal surgery
- Patients with removed turbinates and/or septum, not suffering from ENS (i.e. tumor patients)
Key exclusion criteria (3 listed)
- Patients with known neurologic disorders that could compromise perception threshold measurements
- Patients with known allergies/intolerance to test agents that are used to measure perception thresholds (Cineol=Eucalypt; Menthol, CO2= Carbon Dioxide)
- Inability to judge or understand the testing or the informed consent
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 |
|---|---|---|
| Nasal surgeryAlso: Septoplasty, Turbinoplasty, Removal of turbinates and septum parts | Procedure or surgery | Patients receiving nose surgery |
Primary outcome
Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression
Time frame: Up to 1 year post-surgery
1 secondary outcome
Differences between trigeminal perception threshold as as well as TRP expression levels in patients with postoperative empty nose syndrome and patients with subjectively unimpaired nasal breathing after extended intranasal surgery
Time frame: Up to 1 year post-op
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 12 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Empty Nose Syndrome
Not yet recruiting
Acoustic Resonance Therapy for Treating Empty Nose Syndrome
Empty Nose Syndrome, Nasal Obstruction
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.
Michael Soyka, Dr.med. principal investigator
Zurich University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal surgery in people with Empty Nose Syndrome, run by University of Zurich at 1 site in Switzerland.
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 3 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 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression (time frame: Up to 1 year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2018; AzTrials last refreshed its copy on 31 Oct 2026.