Effects of Surgical Correction of Nasal Obstruction on Oxygen Uptake and Ventilation Volume

NCT ID: NCT06957262

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasal Obstruction Septoplasty Surgeries Athletic Performance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This study was conducted without masking. Participants and investigators were aware of group assignments due to the nature of the intervention (surgical septoplasty). Outcome assessments (aerobic performance tests and symptom questionnaires) were conducted using objective measures and standardized procedures to minimize bias.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Surgical correction of nasal obstruction

Intervention Type PROCEDURE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgical correction of nasal obstruction

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Akdeniz University, Scientific Research Projects Coordination Unit

UNKNOWN

Sponsor Role collaborator

Tuba Melekoğlu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tuba Melekoğlu

Assoc. Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tuba Melekoğlu, Phd

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University Faculty of Sport Sciences

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TYL-2016-1350

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.