- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06957262
Effects of Surgical Correction of Nasal Obstruction on Oxygen Uptake and Ventilation Volume
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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):
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Athletes Undergoing Septoplasty (EG)
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.
|
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.
|
|
No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 2-3 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Oxygen Consumption (VO₂ max and submax VO₂)
Time Frame: Baseline and 2-3 months post-surgery
|
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.
|
Baseline and 2-3 months post-surgery
|
|
Change in Ventilation
Time Frame: Baseline and 2-3 months post-surgery
|
Ventilatory volume was measured during each stage of the treadmill test.
Increases in ventilation at submaximal intensities suggest improved airway function and respiratory efficiency.
|
Baseline and 2-3 months post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tuba Melekoğlu, Phd, Akdeniz University Faculty of Sport Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TYL-2016-1350
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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