Nasal ObstructionISOtastic!NCT05948800
Impact of Nasal Isotonic Solution Irigation on Healthy Athletes' Nasal Flow and Nasal Obstruction Exercise Outcomes
A study testing Nasal irrigation with seawater isotonic solution in people with Nasal Obstruction and Nasal Disease, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction, Nasal Disease
- What is being tested?
- Nasal irrigation with seawater isotonic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 16 Apr 2023to 31 Dec 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Center Sestre milosrdnice
Zagreb, 10000
Andro Košec, MD, PhD, +385989817156, andro.kosec@yahoo.com
Ana Gašić, MD, +385996879905, anagasic4@gmail.com
About this study
Official title: Effect of Isotonic Seawater Solution on Nasal Patency in Athletes: an Interventional Randomized Prospective Cohort Study
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.
Read more
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.
Read the 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.
- Conditions
- Nasal Obstruction, Nasal Disease
- Being tested
- Nasal irrigation with seawater isotonic solution
- Keywords
- nasal irrigation, isotonic solution, NOSE questionnaire, Peak Inspiratory Nasal Flow, Excercise
- Medical subject headings
- Nasal Obstruction, Nose Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal irrigation with seawater isotonic solutionDietary supplement
Isotonic sea water: product from the market, Aqua Maris nasal spray (manufacturer JGL, Rijeka), applied in accordance with the approved Instructions for Consumers.
| Study group | Role | What they receive |
|---|---|---|
| Spraying group | Experimental | 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). Receives: Dietary Supplement: Nasal irrigation with seawater isotonic solution |
| Non-spraying group | No intervention | The control group will not use such a solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak nasal inspiratory flow
The primary outcome measures will be nasal airflow measured with a peak nasal inspiratory flow meter (PNIF).
Measured: Prior to excercise, on the first day after training and on the seventh day after training.
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.
Measured: Prior to excercise, on the first day after training and on the seventh day after training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start16 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Collaborators
- Jadran Galenski laboratorij d.d.
- Responsible party
- Principal investigator, Andro Košec, MD, PhD, University Hospital Sestre Milosrdnice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948800
- Sponsor's protocol ID
- EP 25I-29-II13-23-03
- Acronym
- ISOtastic!
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isotonic Seawater Solution on Nasal Patency in Athletes: an Interventional Randomized Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05948800
- Acronym / sponsor ID
- ISOtastic! / EP 25I-29-II13-23-03
- Conditions
- Nasal Obstruction, Nasal Disease
- Keywords
- nasal irrigation, isotonic solution, NOSE questionnaire, Peak Inspiratory Nasal Flow, Excercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Collaborators
- Jadran Galenski laboratorij d.d.
- Study start
- 16 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Jul 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Spraying group | Experimental | Dietary Supplement: Nasal irrigation with seawater isotonic solutionThe 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). |
| Non-spraying group | No intervention | –The control group will not use such a solution. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Nasal irrigation with seawater isotonic solutionIsotonic sea water: product from the market, Aqua Maris nasal spray (manufacturer JGL, Rijeka), applied in accordance with the approved Instructions for Consumers. | Dietary supplement | Spraying group |
Primary outcome
Peak nasal inspiratory flow
Time frame: Prior to excercise, on the first day after training and on the seventh day after training.
The primary outcome measures will be nasal airflow measured with a peak nasal inspiratory flow meter (PNIF).
NOSE questionnaire
Time frame: Prior to excercise, on the first day after training and on the seventh day after training.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal irrigation with seawater isotonic solution in people with Nasal Obstruction and Nasal Disease, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak nasal inspiratory flow (time frame: Prior to excercise, on the first day after training and on the seventh day after training.). The study lists 2 primary outcomes in all. 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 17 Jul 2023.