Nasal PatencyNOSEjobNCT07127848
Investingation on Outcomes After Combining Septoplasty With Additional Procedures.
A study testing Septoplasty with Mucotomy, Septoplasty with Turbinectomy and Septoplasty with Valvuloplasty in people with Nasal Patency and Breathing Disorder During Sleeping, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
Trial summary
The aim of this study will be to compare postoperative nasal airflow and symptom improvement using a NOSE form in patients after different types of surgical treatment. Patients will be treated with one of the following operations: septoplasty with turbinectomy, septoplasty with radiofrequent ablation of the nasal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Patency, Breathing Disorder During Sleeping, Breathing Mechanics
- What is being tested?
- Septoplasty with Mucotomy, Septoplasty with Turbinectomy and Septoplasty with Valvuloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2025to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were 18 years and above, without any disease or condition affecting nasal breathing apart from allergic rhinitis, septal deviation, hypertrophy of the nasal turbinates.
Who cannot join
- Patients with a history of psychological or mental illness, prior nasal surgery or nasal polyposis were excluded from the study. Use of any medication related to airway management or nasal patency, such as decongestants or mucolytics, or nasal dilators to influence the external and internal nasal valve function during the study period was not allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing Outcomes in Patients Who Underwent Septoplasty With Mucotomy, Turbinectomy, Or Valvuloplasty
The aim of this study will be to compare postoperative nasal airflow and symptom improvement using a NOSE form in patients after different types of surgical treatment. Patients will be treated with one of the following operations: septoplasty with turbinectomy, septoplasty with radiofrequent ablation of the nasal turbinates, or septoplasty with valvuloplasty.
This is a single-center prospective randomized interventional comparative study on patients in a tertiary rhinology center, who will undergo septoplasty alongside one additional rhinologic procedure aimed at improving nasal patency.
Read the detailed description
Inclusion criteria will be met if patients are 18 years and above, without any disease or condition affecting nasal breathing apart from allergic rhinitis, septal deviation, hypertrophy of the nasal turbinates. The criteria require complete follow-up during the testing phases, complete documentation, written informed consent and all questionnaire-related data to be complete.
The patients will be divided into three groups: those undergoing septoplasty with turbinectomy, those undergoing septoplasty with flaring sutures of the internal nasal valve and those undergoing septoplasty with radiofrequent ablation of the inferior nasal turbinates. Randomization will be performed via a binary coin-toss method, with allocation con-cealment, and using a heads-tails method on a true random number generator online service (TRNG).
Patients with a history of psychological or mental illness, prior nasal surgery or nasal polyposis will be excluded from the study. Use of any medication related to airway management or nasal patency, such as decongestants or mucolytics, or nasal dilators to influence the external and internal nasal valve function during the study period was not allowed.
Written informed consent will be obtained from all of the eligible patients. Primary outcome measures include subjective NOSE (Nasal Obstruction Symptom Evaluation) questionnaire scores - internationally validated scale for assessment of intensity of nasal obstruction, consisting of 5 claims related to nasal obstruction divided into Likert scales of 4 points for each claim (normal values 2.75-7, with scores >7 indicating clinically relevant nasal obstruction), and objective peak nasal inspiratory flow measurements using a calibrated instrument (PNIF, GM Instruments, with normal values ranging from 130-140 l/min for healthy young adults), while anthropometric and demographic variables will be covariates[12].
PNIF is a noninvasive, easy to perform method commonly used to assess nasal patency. It is a physiologic measure indicating the peak nasal airflow in liters per minute achieved during maximal forced nasal inspiration [ ]. To reduce test-retest variability and sampling bias due to the influence of the elasticity of the lateral nasal wall (the valve effect), three PNIF measurements will be performed preoperatively and repeated at onset and three months postoperatively, with the best measurement recorded for data analysis.
The study was designed to comply with CONSORT guidelines. A minimal study sample of 90 was calculated based on 80% study power and alpha error rate of 5% (G*Power t-test).
- Being tested
- Septoplasty with Mucotomy, Septoplasty with Turbinectomy, Septoplasty with Valvuloplasty
- Keywords
- septoplasty, turbinectomy, Valvuloplasty, mucotomy, breathing outcome, nasal breathing
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septoplasty with MucotomyProcedure or surgery
Subtotal reconstruction of the nasal septum accompanied by radiofrequent nasal mucosal reduction of the inferior turbinates.
Septoplasty with TurbinectomyProcedure or surgery
Subtotal reconstruction of the nasal septum accompanied by surgical resection of the inferior turbinates.
Septoplasty with ValvuloplastyProcedure or surgery
Subtotal reconstruction of the nasal septum accompanied by surgical intervention by placing a flare sutture in the internal nasal valve area.
| Study group | Role | What they receive |
|---|---|---|
| Septoplasty with Mucotomy | Active comparator | Septoplasty accompanied by radiofrequent mucotomy of the inferior nasal turbinates. Receives: Procedure: Septoplasty with Valvuloplasty |
| Septoplasty and Turbinectomy | Active comparator | Septoplasty accompanied by surgical resection of the inferior nasal turbinates. Receives: Procedure: Septoplasty with Mucotomy |
| Septoplasty and Valvuloplasty | Active comparator | Septoplasty accompanied by placing a flaring sutture in the internal nasal valve area. Receives: Procedure: Septoplasty with Turbinectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PNIF
Peak Nasal Inspiratory Flow measurement - objective measurement of nasal patency in liters per minute.
Measured: Every months until six months postoperatively.
NOSE questionnaire
Validated PROM regarding subjective nasal patency assessment.
Measured: Every month up to 6 months post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Apr 2025
- Primary completion3 Sep 2025 (estimated)
- Study completion3 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal PatencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomized into three groups: those undergoing septoplasty with turbinectomy, those undergoing septoplasty with flaring sutures of the internal nasal valve and those undergoing septoplasty with radiofrequent ablation of the inferior nasal turbinates.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andro Košec, MD, PhD, University Hospital Sestre Milosrdnice
- Investigators
- Andro Košec, MD, PhD, FEBORL-HNS, FACS, Study chair, University Hospital Center Sestre milosrdnice, Department of ORL&HNS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127848
- Sponsor's protocol ID
- 2025-001
- Acronym
- NOSEjob
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hernandez AK, Uhl C, Haehner A, Cuevas M, Hummel T. Objective nasal airflow measures in relation to subjective nasal obstruction, trigeminal function, and olfaction in patients with chronic rhinosinusitis. Rhinology. 2024 Aug 1;62(4):394-402. doi: 10.4193/Rhin23.270.
PubMed 38507726
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Outcomes in Patients Who Underwent Septoplasty With Mucotomy, Turbinectomy, Or Valvuloplasty
- ClinicalTrials.gov ID
- NCT07127848
- Acronym / sponsor ID
- NOSEjob / 2025-001
- Keywords
- septoplasty, turbinectomy, Valvuloplasty, mucotomy, breathing outcome, nasal breathing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 3 Sep 2025 (estimated)
- Study completion
- 3 Sep 2025 (estimated)
- First posted
- 17 Aug 2025 (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 aim of this study will be to compare postoperative nasal airflow and symptom improvement using a NOSE form in patients after different types of surgical treatment. Patients will be treated with one of the following operations: septoplasty with turbinectomy, septoplasty with radiofrequent ablation of the nasal turbinates, or septoplasty with valvuloplasty.
This is a single-center prospective randomized interventional comparative study on patients in a tertiary rhinology center, who will undergo septoplasty alongside one additional rhinologic procedure aimed at improving nasal patency.
Detailed description
Inclusion criteria will be met if patients are 18 years and above, without any disease or condition affecting nasal breathing apart from allergic rhinitis, septal deviation, hypertrophy of the nasal turbinates. The criteria require complete follow-up during the testing phases, complete documentation, written informed consent and all questionnaire-related data to be complete.
The patients will be divided into three groups: those undergoing septoplasty with turbinectomy, those undergoing septoplasty with flaring sutures of the internal nasal valve and those undergoing septoplasty with radiofrequent ablation of the inferior nasal turbinates. Randomization will be performed via a binary coin-toss method, with allocation con-cealment, and using a heads-tails method on a true random number generator online service (TRNG).
Patients with a history of psychological or mental illness, prior nasal surgery or nasal polyposis will be excluded from the study. Use of any medication related to airway management or nasal patency, such as decongestants or mucolytics, or nasal dilators to influence the external and internal nasal valve function during the study period was not allowed.
Written informed consent will be obtained from all of the eligible patients. Primary outcome measures include subjective NOSE (Nasal Obstruction Symptom Evaluation) questionnaire scores - internationally validated scale for assessment of intensity of nasal obstruction, consisting of 5 claims related to nasal obstruction divided into Likert scales of 4 points for each claim (normal values 2.75-7, with scores >7 indicating clinically relevant nasal obstruction), and objective peak nasal inspiratory flow measurements using a calibrated instrument (PNIF, GM Instruments, with normal values ranging from 130-140 l/min for healthy young adults), while anthropometric and demographic variables will be covariates[12].
PNIF is a noninvasive, easy to perform method commonly used to assess nasal patency. It is a physiologic measure indicating the peak nasal airflow in liters per minute achieved during maximal forced nasal inspiration [ ]. To reduce test-retest variability and sampling bias due to the influence of the elasticity of the lateral nasal wall (the valve effect), three PNIF measurements will be performed preoperatively and repeated at onset and three months postoperatively, with the best measurement recorded for data analysis.
The study was designed to comply with CONSORT guidelines. A minimal study sample of 90 was calculated based on 80% study power and alpha error rate of 5% (G*Power t-test).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The patients will be randomized into three groups: those undergoing septoplasty with turbinectomy, those undergoing septoplasty with flaring sutures of the internal nasal valve and those undergoing septoplasty with radiofrequent ablation of the inferior nasal turbinates.
| Arm | Type | Receives |
|---|---|---|
| Septoplasty with Mucotomy | Active comparator | Procedure: Septoplasty with ValvuloplastySeptoplasty accompanied by radiofrequent mucotomy of the inferior nasal turbinates. |
| Septoplasty and Turbinectomy | Active comparator | Procedure: Septoplasty with MucotomySeptoplasty accompanied by surgical resection of the inferior nasal turbinates. |
| Septoplasty and Valvuloplasty | Active comparator | Procedure: Septoplasty with TurbinectomySeptoplasty accompanied by placing a flaring sutture in the internal nasal valve area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were 18 years and above, without any disease or condition affecting nasal breathing apart from allergic rhinitis, septal deviation, hypertrophy of the nasal turbinates.
Key exclusion criteria (1 listed)
- Patients with a history of psychological or mental illness, prior nasal surgery or nasal polyposis were excluded from the study. Use of any medication related to airway management or nasal patency, such as decongestants or mucolytics, or nasal dilators to influence the external and internal nasal valve function during the study period was not allowed.
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 |
|---|---|---|
| Septoplasty with MucotomySubtotal reconstruction of the nasal septum accompanied by radiofrequent nasal mucosal reduction of the inferior turbinates. | Procedure or surgery | Septoplasty and Turbinectomy |
| Septoplasty with TurbinectomySubtotal reconstruction of the nasal septum accompanied by surgical resection of the inferior turbinates. | Procedure or surgery | Septoplasty and Valvuloplasty |
| Septoplasty with ValvuloplastySubtotal reconstruction of the nasal septum accompanied by surgical intervention by placing a flare sutture in the internal nasal valve area. | Procedure or surgery | Septoplasty with Mucotomy |
Primary outcome
PNIF
Time frame: Every months until six months postoperatively.
Peak Nasal Inspiratory Flow measurement - objective measurement of nasal patency in liters per minute.
NOSE questionnaire
Time frame: Every month up to 6 months post surgery.
Validated PROM regarding subjective nasal patency assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Background: PubMed 38507726Hernandez AK, Uhl C, Haehner A, Cuevas M, Hummel T. Objective nasal airflow measures in relation to subjective nasal obstruction, trigeminal function, and olfaction in patients with chronic rhinosinusitis. Rhinology. 2024 Aug 1;62(4):394-402. doi: 10.4193/Rhin23.270.
- Individual participant dataSharing planned: No
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.
Andro Košec, MD, PhD, FEBORL-HNS, FACS study chair
University Hospital Center Sestre milosrdnice, Department of ORL&HNS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septoplasty with Mucotomy, Septoplasty with Turbinectomy and Septoplasty with Valvuloplasty in people with Nasal Patency and Breathing Disorder During Sleeping, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 17 Aug 2025. 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 Croatia. 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?
This study is still under way. Results are not available in the source record yet.
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?
PNIF (time frame: Every months until six months postoperatively.). The study lists 2 primary outcomes in all. 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 NCT07127848, which also lists 1 linked publication.
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 17 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.