Nasal ObstructionNCT06957262
Effects of Surgical Correction of Nasal Obstruction on Oxygen Uptake and Ventilation Volume
A study testing Surgical correction of nasal obstruction in people with Nasal Obstruction and Septoplasty Surgeries, run by Tuba Melekoğlu.
Trial summary
This retrospective study aims to evaluate the effect of surgical correction of nasal obstruction on aerobic performance parameters in male athletes aged 20-32 years. The main questions it aims to answer are: Does nasal obstruction surgery impact running economy and ventilation during exercise? Does it affect oxygen… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction, Septoplasty Surgeries, Athletic Performance
- What is being tested?
- Surgical correction of nasal obstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 15 Jan 2020
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For Experimental Group (EG):
- Diagnosed with nasal obstruction due to septal deviation and/or inferior turbinate hypertrophy
- Experiencing nasal breathing difficulties and sleep disturbance
- Deemed eligible for septoplasty and/or inferior turbinoplasty following physical and endoscopic examination
- Voluntarily agreed to participate in the study
- For Control Group (CG):
Show all 9Show fewer
- No reported nasal obstruction or breathing complications
- Matched with EG participants by age, sport discipline, training level, and VO₂max (with a maximum variation of ±5%)
- Willing to follow a similar training program to their matched EG counterparts between pre- and post-testing periods
Who cannot join
- History of nasal surgery
- Presence of cardiopulmonary diseases
- Musculoskeletal disorders affecting physical performance or exercise testing
- Inability or unwillingness to follow the pre- and post-test training schedule
- Any surgical complication that would interfere with post-operative participation in physical testing (note: none occurred in this study)
About this study
This retrospective study aims to evaluate the effect of surgical correction of nasal obstruction on aerobic performance parameters in male athletes aged 20-32 years. The main questions it aims to answer are:
- Does nasal obstruction surgery impact running economy and ventilation during exercise?
- Does it affect oxygen consumption during submaximal running efforts?
Read more
Researchers will retrospectively compare male athletes who underwent nasal obstruction surgery (experimental group) to matched athletes without nasal obstruction (control group) to assess changes in respiratory function and exercise performance.
Participants were assessed by:
- Acoustic rhinometry to measure nasal cavity dimensions.
- The Nasal Obstruction Symptom Evaluation (NOSE) scale and Epworth Sleepiness Scale (ESS) to evaluate nasal obstruction symptoms and daytime sleepiness.
- Incremental treadmill exercise tests to collect data on gas exchange, oxygen consumption, ventilation, and running economy before and after the surgical intervention (or across a similar time period for the control group).
- Being tested
- Surgical correction of nasal obstruction
- Keywords
- nasal surgery, aerobic performance, exercise economy, respiratory work
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical correction of nasal obstructionProcedure or surgery
Surgical intervention to correct anatomical nasal obstruction, specifically septal deviation, performed under general anesthesia. The procedure involved the repositioning and reshaping of the deviated nasal septum to improve nasal airflow. The surgery was conducted by an otolaryngologist with experience in nasal airway procedures. No additional medications or postoperative interventions beyond standard care (e.g., saline irrigation, analgesics) were administered. Postoperative assessments occurred 2-3 months after surgery, including evaluations of nasal patency, sleep quality, and aerobic performance using treadmill-based gas exchange measurements.
| Study group | Role | What they receive |
|---|---|---|
| Athletes Undergoing Septoplasty (EG) | Experimental | This arm included male athletes diagnosed with nasal obstruction who underwent surgical correction via septoplasty. Participants were evaluated before and approximately 2-3 months after surgery. Assessments included acoustic rhinometry to measure nasal cavity cross-sectional areas and volumes, the Epworth Sleepiness Scale (ESS), and the Nasal Obstruction Symptom Evaluation (NOSE) scale. Aerobic performance parameters such as running economy, oxygen consumption, and ventilation volume were measured using an incremental treadmill test and respiratory gas analysis. Receives: Procedure: Surgical correction of nasal obstruction |
| Control Group | No intervention | Male athletes without nasal obstruction, matched by age and training level with the experimental group. They did not receive any intervention but underwent the same aerobic performance testing protocol at the same time points for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Running Economy (ml/kg/min)
Running economy was assessed via an incremental treadmill test by measuring steady-state oxygen consumption (VO₂) at submaximal running speeds (e.g., 8, 10, 12 km/h). Improvement in running economy is defined by a decrease in VO₂ at the same speed, indicating greater efficiency.
Measured: Baseline and 2-3 months post-surgery
Secondary outcomes (2)
Change in Oxygen Consumption (VO₂ max and submax VO₂)
Peak and submaximal oxygen consumption were evaluated using gas exchange analysis during a graded treadmill test. Reduced submaximal VO₂ values are indicative of improved aerobic performance.
Measured: Baseline and 2-3 months post-surgery
Change in Ventilation
Ventilatory volume was measured during each stage of the treadmill test. Increases in ventilation at submaximal intensities suggest improved airway function and respiratory efficiency.
Measured: Baseline and 2-3 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 posted4 May 2025
- Study start1 Jan 2017
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies 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
- Participants were assigned to one of two parallel groups: an experimental group consisting of athletes with nasal obstruction undergoing septoplasty, and a control group of matched athletes without nasal obstruction who did not receive any intervention. Both groups underwent the same aerobic performance evaluations at baseline and at follow-up (2-3 months).
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuba Melekoğlu
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University, Scientific Research Projects Coordination Unit
- Responsible party
- Sponsor-investigator, Tuba Melekoğlu, Akdeniz University
- Investigators
- Tuba Melekoğlu, Phd, Principal investigator, Akdeniz University Faculty of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957262
- Sponsor's protocol ID
- TYL-2016-1350
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Surgical Correction of Nasal Obstruction on Oxygen Uptake and Ventilation Volume
- ClinicalTrials.gov ID
- NCT06957262
- Acronym / sponsor ID
- TYL-2016-1350
- Keywords
- nasal surgery, aerobic performance, exercise economy, respiratory work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Tuba MelekoğluUniversity, hospital or other
- Collaborators
- Akdeniz University, Scientific Research Projects Coordination Unit
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 4 May 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.
This retrospective study aims to evaluate the effect of surgical correction of nasal obstruction on aerobic performance parameters in male athletes aged 20-32 years. The main questions it aims to answer are:
- Does nasal obstruction surgery impact running economy and ventilation during exercise?
- Does it affect oxygen consumption during submaximal running efforts?
Researchers will retrospectively compare male athletes who underwent nasal obstruction surgery (experimental group) to matched athletes without nasal obstruction (control group) to assess changes in respiratory function and exercise performance.
Participants were assessed by:
- Acoustic rhinometry to measure nasal cavity dimensions.
- The Nasal Obstruction Symptom Evaluation (NOSE) scale and Epworth Sleepiness Scale (ESS) to evaluate nasal obstruction symptoms and daytime sleepiness.
- Incremental treadmill exercise tests to collect data on gas exchange, oxygen consumption, ventilation, and running economy before and after the surgical intervention (or across a similar time period for the control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel groups: an experimental group consisting of athletes with nasal obstruction undergoing septoplasty, and a control group of matched athletes without nasal obstruction who did not receive any intervention. Both groups underwent the same aerobic performance evaluations at baseline and at follow-up (2-3 months).
| Arm | Type | Receives |
|---|---|---|
| Athletes Undergoing Septoplasty (EG) | Experimental | Procedure: Surgical correction of nasal obstructionThis arm included male athletes diagnosed with nasal obstruction who underwent surgical correction via septoplasty. Participants were evaluated before and approximately 2-3 months after surgery. Assessments included acoustic rhinometry to measure nasal cavity cross-sectional areas and volumes, the Epworth Sleepiness Scale (ESS), and the Nasal Obstruction Symptom Evaluation (NOSE) scale. Aerobic performance parameters such as running economy, oxygen consumption, and ventilation volume were measured using an incremental treadmill test and respiratory gas analysis. |
| Control Group | No intervention | –Male athletes without nasal obstruction, matched by age and training level with the experimental group. They did not receive any intervention but underwent the same aerobic performance testing protocol at the same time points for comparison. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Diagnosed with nasal obstruction due to septal deviation and/or inferior turbinate hypertrophy
- Experiencing nasal breathing difficulties and sleep disturbance
- Deemed eligible for septoplasty and/or inferior turbinoplasty following physical and endoscopic examination
- Voluntarily agreed to participate in the study
- For Control Group (CG):
Key exclusion criteria (5 listed)
- History of nasal surgery
- Presence of cardiopulmonary diseases
- Musculoskeletal disorders affecting physical performance or exercise testing
- Inability or unwillingness to follow the pre- and post-test training schedule
- Any surgical complication that would interfere with post-operative participation in physical testing (note: none occurred in this study)
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 |
|---|---|---|
| Surgical correction of nasal obstructionSurgical intervention to correct anatomical nasal obstruction, specifically septal deviation, performed under general anesthesia. The procedure involved the repositioning and reshaping of the deviated nasal septum to improve nasal airflow. The surgery was conducted by an otolaryngologist with experience in nasal airway procedures. No additional medications or postoperative interventions beyond standard care (e.g., saline irrigation, analgesics) were administered. Postoperative assessments occurred 2-3 months after surgery, including evaluations of nasal patency, sleep quality, and aerobic performance using treadmill-based gas exchange measurements. | Procedure or surgery | Athletes Undergoing Septoplasty (EG) |
Primary outcome
Change in Running Economy (ml/kg/min)
Time frame: Baseline and 2-3 months post-surgery
Running economy was assessed via an incremental treadmill test by measuring steady-state oxygen consumption (VO₂) at submaximal running speeds (e.g., 8, 10, 12 km/h). Improvement in running economy is defined by a decrease in VO₂ at the same speed, indicating greater efficiency.
2 secondary outcomes
Change in Oxygen Consumption (VO₂ max and submax VO₂)
Time frame: Baseline and 2-3 months post-surgery
Change in Ventilation
Time frame: Baseline and 2-3 months post-surgery
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 4 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Tuba Melekoğlu, Phd principal investigator
Akdeniz University Faculty of Sport Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Surgical correction of nasal obstruction in people with Nasal Obstruction and Septoplasty Surgeries, run by Tuba Melekoğlu.
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 9 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 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Running Economy (ml/kg/min) (time frame: Baseline and 2-3 months 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 4 May 2025.