NCT05948800: ISOtastic!

Impact of Nasal Isotonic Solution Irigation on Healthy Athletes' Nasal Flow and Nasal Obstruction Exercise Outcomes

Status unknown NA Last updated 17 July 2023

What this trial tests

NA trial testing Nasal irrigation with seawater isotonic solution in Nasal Obstruction in 50 participants. Status unknown.

Timeline

16 April 2023

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	University Hospital Sestre Milosrdnice
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	16 April 2023
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Croatia

Drugs / interventions tested

• Nasal irrigation with seawater isotonic solution

Conditions studied

• Nasal Obstruction — all drugs for Nasal Obstruction →
• Nasal Disease — all drugs for Nasal Disease →

Sponsor

University Hospital Sestre Milosrdnice

Who can join

Adults 18 to 40, any sex, with Nasal Obstruction or Nasal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Nasal patency is an important component of performing exercises because it helps in humidifying, heating and filtering the inhaled air. However, many athletes and exercisers experience difficulty breathing through their nose, which can affect their breathing and performance. Namely, during sports activities and greater physical effort, there is increased air flow, which causes significant dehydration and cooling of the mucous membrane of the upper respiratory system. This dehydration is associated with the release of inflammatory mediators, which can ultimately lead to narrowing of the airways (eg in athletes with asthma). However, in all athletes, regardless of whether they have asthma or not, damage to the airways can occur because during exercise, hyperpnea exposes the respiratory epithelium to increased physical forces and pressure, which leads to the risk of exfoliation of the previously dehydrated epithelial cells of the nose and even their complete separation. Repeated stretching and compression can negatively affect the functionality of the epithelium and, with repeated exposure and damage, lead to structural and functional changes.

Rinsing the nose with a hypertonic or isotonic solution of seawater is a potential solution for nasal obstruction because after rinsing, the airflow through the nose improves and symptoms of obstruction are reduced. However, the effects of using nasal lavage solutions along with exercise in elite athletes are not yet known. The potential synergy of exercise and isotonic seawater solution as a nasal spray on airflow and the subjective impression of nasal patency in healthy individuals has not been sufficiently investigated5.

Research question

What is the effect of an isotonic seawater solution applied as a nasal spray on nasal airflow and the subjective impression of nasal obstruction in healthy athletes?

Hypothesis

An isotonic seawater solution applied as a nasal spray will improve nasal airflow and the subjective impression of nasal obstruction in healthy athletes.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparing Nasal Patency Outcomes in Patients Undergoing Septoplasty with Radiofrequency Turbinate Reduction, Turbinectomy, or Valvuloplasty: A Prospective Cohort Study.
   Tomljenović D, Grgurić L, Knežević M, Svetina L, et al · · 2025 · PMID 41011047 · DOI 10.3390/medicina61091656
2. The Impact of Isotonic Seawater on Subjective and Objective Nose Patency in Athletes: A Randomized Controlled Trial.
   Košec A, Vlahović T, Šilović B, Rakić M, et al · · 2025 · PMID 40283574 · DOI 10.3390/jcm14082742