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Impact of Nasal Isotonic Solution Irigation on Healthy Athletes' Nasal Flow and Nasal Obstruction Exercise Outcomes (ISOtastic!)

Primary Purpose

Nasal Obstruction, Nasal Disease

Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Nasal irrigation with seawater isotonic solution
Sponsored by
University Hospital "Sestre Milosrdnice"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction focused on measuring nasal irrigation, isotonic solution, NOSE questionnaire, Peak Inspiratory Nasal Flow, Excercise

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 50 healthy adult athletes between the ages of 18 and 35 will be engaged in the research (power analysis with 80% power and an alpha error of 5% shows that 32 subjects in two groups are sufficient). Exclusion Criteria: Bacterial or viral acute inflammation of the upper respiratory system, chronic obstruction of one or both nostrils with significant deformation of the septum, surgery on the nose or nasal septum within one month of the start of the study

Sites / Locations

  • University Hospital Center Sestre milosrdniceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Spraying group

Non-spraying group

Arm Description

The first group will use an isotonic seawater solution as a nasal spray for 10 days. The group with the isotonic seawater solution applied as a nasal spray will use it at least three times a day, and necessarily before exercise (about 20 minutes before).

The control group will not use such a solution.

Outcomes

Primary Outcome Measures

Peak nasal inspiratory flow
The primary outcome measures will be nasal airflow measured with a peak nasal inspiratory flow meter (PNIF).
NOSE questionnaire
Subjective impression of symptoms of nasal obstruction before and after exercise by completing the NOSE questionnaire. The NOSE contains five statements about nasal obstruction, divided on a 4-point Likert scale for each statement.

Secondary Outcome Measures

Full Information

First Posted
July 9, 2023
Last Updated
July 9, 2023
Sponsor
University Hospital "Sestre Milosrdnice"
Collaborators
Jadran Galenski laboratorij d.d.
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1. Study Identification

Unique Protocol Identification Number
NCT05948800
Brief Title
Impact of Nasal Isotonic Solution Irigation on Healthy Athletes' Nasal Flow and Nasal Obstruction Exercise Outcomes
Acronym
ISOtastic!
Official Title
Effect of Isotonic Seawater Solution on Nasal Patency in Athletes: an Interventional Randomized Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital "Sestre Milosrdnice"
Collaborators
Jadran Galenski laboratorij d.d.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Subjects and Methods Participants: 50 healthy adult athletes between the ages of 18 and 35 will be engaged in the research (power analysis with 80% power and an alpha error of 5% shows that 32 subjects in two groups are sufficient). Exclusion criteria: Bacterial or viral acute inflammation of the upper respiratory system, chronic obstruction of one or both nostrils with significant deformation of the septum, surgery on the nose or nasal septum within one month of the start of the study Isotonic seawater: product from the market, Aqua Maris nasal spray (manufacturer JGL, Rijeka), applied in accordance with the approved Instructions for Consumers Study design: A randomized, interventional prospective cohort study. Intervention: The participants will be divided into two groups using the binary coin-toss method (random.org) with similar physical and demographic characteristics. The first group will use an isotonic seawater solution as a nasal spray for 10 days, while the control group will not use such a solution. The group with the isotonic seawater solution applied as a nasal spray will use it at least three times a day, and necessarily before exercise (about 20 minutes before). Outcome measures: The primary outcome measures will be nasal airflow measured with a peak nasal inspiratory flow meter (PNIF) and subjective impression of nasal obstruction symptoms before and after exercise by completing the NOSE questionnaire. The NOSE contains five statements about nasal obstruction, divided on a 4-point Likert scale for each statement. Remark: PNIF meters will be provided by JGL (measurement with them takes < 1 min/athlete) The NOSE questionnaire (abbreviated from Nasal Obstruction Symptom Evaluation) is an internationally recognized and validated scale for assessing the intensity of nasal obstruction. The time points for the collection of measures will be: Day 1: before the start of the research, before the first training session (first interval), respectively: NOSE PNIF Day 1: after the first use of the spray, (within 20 minutes after the first training session - second interval), i.e. after the first training session in the control group, respectively: NOSE PNIF Day 7: after ten days of daily use of the spray, after training (third interval) or after the first training in the control group, respectively: NOSE PNIF Data analysis: Descriptive statistics and inferential statistics will be used to compare outcomes between two groups (no less than 16 participants in the nasal spray group vs. no less than 16 participants without the spray). Each couple from the test group will be joined by a couple from the control group with as similar physical and demographic characteristics as possible. The Wilcoxon signed rank test and the Friedman test for paired samples will be used depending on the distribution of the data. Ethical considerations This study will be conducted in accordance with ethical principles and guidelines (1996 Helsinki Declaration, in accordance with current Croatian regulations, and after approval by the competent hospital ethics committee). Written informed consent will be obtained from all participants. Participants will be informed of the risks and benefits of the study by the examining physician. The confidentiality of the participant's data will be ensured in such a way as to comply with GDPR provisions in accordance with EU and national legislation. Conclusion This study aims to investigate the effects of an isotonic solution of seawater from the Adriatic Sea applied as a nasal spray on: subjective nasal patency nasal airflow in healthy athletes. The results of this research could help athletes improve performance by improving nasal airflow and nasal function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Nasal Disease
Keywords
nasal irrigation, isotonic solution, NOSE questionnaire, Peak Inspiratory Nasal Flow, Excercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants will be divided into two groups using the binary coin-toss method (random.org) with similar physical and demographic characteristics. The first group will use an isotonic seawater solution as a nasal spray for 10 days, while the control group will not use such a solution. The group with the isotonic seawater solution applied as a nasal spray will use it at least three times a day, and necessarily before exercise (about 20 minutes before).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spraying group
Arm Type
Experimental
Arm Description
The first group will use an isotonic seawater solution as a nasal spray for 10 days. The group with the isotonic seawater solution applied as a nasal spray will use it at least three times a day, and necessarily before exercise (about 20 minutes before).
Arm Title
Non-spraying group
Arm Type
No Intervention
Arm Description
The control group will not use such a solution.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nasal irrigation with seawater isotonic solution
Intervention Description
Isotonic sea water: product from the market, Aqua Maris nasal spray (manufacturer JGL, Rijeka), applied in accordance with the approved Instructions for Consumers.
Primary Outcome Measure Information:
Title
Peak nasal inspiratory flow
Description
The primary outcome measures will be nasal airflow measured with a peak nasal inspiratory flow meter (PNIF).
Time Frame
Prior to excercise, on the first day after training and on the seventh day after training.
Title
NOSE questionnaire
Description
Subjective impression of symptoms of nasal obstruction before and after exercise by completing the NOSE questionnaire. The NOSE contains five statements about nasal obstruction, divided on a 4-point Likert scale for each statement.
Time Frame
Prior to excercise, on the first day after training and on the seventh day after training.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 50 healthy adult athletes between the ages of 18 and 35 will be engaged in the research (power analysis with 80% power and an alpha error of 5% shows that 32 subjects in two groups are sufficient). Exclusion Criteria: Bacterial or viral acute inflammation of the upper respiratory system, chronic obstruction of one or both nostrils with significant deformation of the septum, surgery on the nose or nasal septum within one month of the start of the study
Facility Information:
Facility Name
University Hospital Center Sestre milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andro Košec, MD, PhD
Phone
+385989817156
Email
andro.kosec@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ana Gašić, MD
Phone
+385996879905
Email
anagasic4@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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