Allergic RhinitisNCT07455968
Free Diving Breathing Training in Allergic Rhinitis
A study testing Free diving breathing training in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study was to investigate the effects of diver-style breathing training on symptoms, pulmonary function, and respiratory muscle, in patients with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Free diving breathing training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2025to 30 Mar 2026
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with persistent allergic rhinitis (allergen of any type), both male and female, presenting with nasal congestion, sneezing, nasal itching, and rhinorrhea occurring more than 4 days per week, with an average symptom score greater than 7. Eligibility was determined using the Rhinitis Symptoms Score (0, 1, 2, and ≥3 scale) assessed over the previous week and on the day of testing. Participants must not have any complications such as sinusitis, Eustachian tube dysfunction, or asthma.
- No history of other respiratory diseases, including bronchitis, pertussis, pneumonia, pneumonitis, pulmonary aspergilloma, tuberculosis, asthma, lung cancer, emphysema, or other related conditions.
- No regular exercise training exceeding 20 minutes per session, 3 days per week or more, during the 6 months prior to participation.
- No regular consumption of vitamin supplements or herbal products at least 3 days per week during the 6 months prior to participation.
- Ability to discontinue the following medications before and during the study period: Antihistamines for at least 3 days, Oral steroids and nasal steroids for at least 2 weeks, Leukotriene receptor antagonists for at least 1 week
- Participants were permitted to use decongestants (pseudoephedrine) if necessary. All participants were advised to consult their primary physician before discontinuing any medication and to ensure that their physical condition was appropriate for participation in the breathing training program.
- Willingness to participate voluntarily and provide written informed consent.
Who cannot join
- Inability to continue participation due to unforeseen circumstances, such as injury or illness.
- Absence from more than 8 training sessions out of a total of 40 sessions.
- Withdrawal of consent or unwillingness to continue participation.
- Inability to discontinue medications according to the specified criteria.
- Exacerbation of allergic rhinitis symptoms that prevents continued participation, such as persistent rhinorrhea or severe nasal congestion causing difficulty breathing.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Sports Science, Chulalongkorn University
Bangkok, Bangkok, 10330
About this study
Official title: Effects of Free Diving Breathing Training on Symptoms in Patients With Allergic Rhinitis
The purpose of this study was to investigate the effects of diver-style breathing training on symptoms, pulmonary function, and respiratory muscle, in patients with allergic rhinitis.
Read the detailed description
This study aims to investigate the effects of diver-style breathing training in patients with allergic rhinitis. A total of 30 patients aged 18-35 years were recruited from students and staff of Chulalongkorn University, as well as patients attending the Chulalongkorn University Health Service Center and King Chulalongkorn Memorial Hospital. Participants were randomly assigned into two groups: an experimental group (n = 15) that received diver-style breathing training and a control group (n = 15) that continued their usual daily activities without any exercise intervention.
The independent variable was diver-style breathing training. The dependent variables included rhinitis symptom outcomes (symptom scores, Peak Nasal Inspiratory Flow, nasal blood flow, and Fractional Exhaled Nitric Oxide), pulmonary function parameters (FVC, FEV1, FEV1/FVC, FEF25-75%, MVV, and breath-holding time), and respiratory muscle strength (MIP and MEP).
- Conditions
- Allergic Rhinitis
- Being tested
- Free diving breathing training
- Keywords
- Free diving breathing, Allergic rhinitis, Rhinitis symptoms, Pulmonary function, Respiratory muscle strength
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free diving breathing trainingOther
The diver-style breathing training program lasts 40 minutes per session. Participants sit upright with proper posture and begin with 5 minutes of normal breathing. They then perform a progressive deep inhalation technique: inhaling through the nose to expand the abdomen, continuing to expand the chest, and finally inhaling further until a sensation of throat tightness is felt. The breath is then held for at least 20 seconds or as long as possible before exhaling through the mouth. Each cycle counts as one round, and participants aim to gradually increase their breath-holding duration over 30 minutes. The session ends with 5 minutes of normal breathing.
| Study group | Role | What they receive |
|---|---|---|
| Free diving breathing training | Experimental | Not described Receives: Other: Free diving breathing training |
| Control group (Normal daily life) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinitis symptom scores
Nasal symptoms were assessed using Total Nasal Symptom Score (TNSS) questionnaire. The subjects were asked to score symptoms of persistent allergic rhinitis before and after yoga training protocol. The total nasal symptom scores were computed as the sum of four individual nasal symptom scores; nasal congestion, itching, sneezing, and rhinorrhea. The scores ranged from 0 to 3 scale (0=none, 1=mild, 2=moderate, 3= severe)
Measured: Change from Baseline Rhinitis symptom scores at 8 weeks.
Peak nasal inspiratory flow; PNIF
Participants were instructed to inhale through the device as quickly and forcefully as possible using a Peak Nasal Inspiratory Flow (PNIF) meter.
Measured: Change from Baseline respiratory muscle strength at 8 weeks.
Nasal blood flow
Laser Doppler flowmetry (DRT4, Moor Instruments, UK) was used to measure the NBF. Before the test, each subject rested for 1 hour in a separate room. During the test, the participants were instructed to breathe normally and not to speak, cough, or move. A lateral endoscopic probe with a flexible 1.34-mm-diameter flexible nylon sheath was placed on the front of the nose.
Measured: Change from Baseline Rhinitis symptom scores at 8 weeks.
Fractional Exhaled Nitric Oxide Testing; FeNO
FeNO Monitor (BedFont, UK) was used to measure the FeNO. The participants inhaled deeply for 2 to 3 seconds before exhaling slowly, which normally took 10 seconds.
Measured: Change from Baseline Rhinitis symptom scores at 8 weeks.
Secondary outcomes (7)
Forced Vital Capacity; FVC
Participants were seated in a chair and wore a nasal clip during the assessment. They first performed three cycles of slow, normal breathing, followed by a demonstration of forced inspiration and expiration, and then returned to normal breathing.
Measured: Change from Baseline respiratory muscle strength at 8 weeks.
Forced Expiratory Volume in one second; FEV1
Participants were seated in a chair and wore a nasal clip during the assessment. They first performed three cycles of slow, normal breathing, followed by a demonstration of forced inspiration and expiration, and then returned to normal breathing.
Measured: Change from Baseline respiratory muscle strength at 8 weeks.
Forced Expiratory Flow at 25-75% of FVC; FEF25 - 75 %
Participants were seated in a chair and wore a nasal clip during the assessment. They first performed three cycles of slow, normal breathing, followed by a demonstration of forced inspiration and expiration, and then returned to normal breathing.
Measured: Change from Baseline respiratory muscle strength at 8 weeks.
Maximum Voluntary Ventilation; MVV
Participants were instructed to breathe in and out as quickly and forcefully as possible for 15 seconds.
Measured: Change from Baseline respiratory muscle strength at 8 weeks.
Breath Holding Time Test
Participants were instructed to inhale as deeply as possible, hold their breath for as long as possible, and then exhale through the mouth.
Measured: Change from Baseline respiratory muscle strength at 8 weeks.
Maximal Inspiratory Pressure; MIP
Participants were instructed to exhale fully to functional residual capacity (FRC), then place the mouthpiece securely and perform a maximal inspiratory effort sustained for 1-2 seconds.
Measured: Change from Baseline respiratory muscle strength at 8 weeks.
Maximal expiratory pressure; MEP
Participants inhaled fully to total lung capacity (TLC), maintained a tight seal on the mouthpiece, and then performed a maximal expiratory effort for 1-2 seconds.
Measured: Change from Baseline respiratory muscle strength at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Aug 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wannaporn Tongtako, Ph.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455968
- Sponsor's protocol ID
- Ex Physio SPSC 12
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ostrowski A, Strzala M, Stanula A, Juszkiewicz M, Pilch W, Maszczyk A. The role of training in the development of adaptive mechanisms in freedivers. J Hum Kinet. 2012 May;32:197-210. doi: 10.2478/v10078-012-0036-2. Epub 2012 May 30.
PubMed 23487544Leelarungrayub J, Puntumetakul R, Sriboonreung T, Pothasak Y, Klaphajone J. Preliminary study: comparative effects of lung volume therapy between slow and fast deep-breathing techniques on pulmonary function, respiratory muscle strength, oxidative stress, cytokines, 6-minute walking distance, and quality of life in persons with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 5;13:3909-3921. doi: 10.2147/COPD.S181428. eCollection 2018.
PubMed 30584292Desai MB, Gavrilova T, Liu J, Patel SA, Kartan S, Greco SJ, Capitle E, Rameshwar P. Pollen-induced antigen presentation by mesenchymal stem cells and T cells from allergic rhinitis. Clin Transl Immunology. 2013 Oct 18;2(10):e7. doi: 10.1038/cti.2013.9. eCollection 2013 Oct.
PubMed 25505949Diniz CM, Farias TL, Pereira MC, Pires CB, Goncalves LS, Coertjens PC, Coertjens M. Chronic adaptations of lung function in breath-hold diving fishermen. Int J Occup Med Environ Health. 2014 Apr;27(2):216-23. doi: 10.2478/s13382-014-0259-7. Epub 2014 Apr 3.
PubMed 24700159Dykewicz MS, Wallace DV, Baroody F, Bernstein J, Craig T, Finegold I, Huang F, Larenas-Linnemann D, Meltzer E, Steven G, Bernstein DI, Blessing-Moore J, Dinakar C, Greenhawt M, Horner CC, Khan DA, Lang D, Oppenheimer J, Portnoy JM, Randolph CR, Rank MA; Workgroup Chair and Cochair; Dykewicz MS, Wallace DV. Treatment of seasonal allergic rhinitis: An evidence-based focused 2017 guideline update. Ann Allergy Asthma Immunol. 2017 Dec;119(6):489-511.e41. doi: 10.1016/j.anai.2017.08.012. Epub 2017 Nov 2. No abstract available.
PubMed 29103802Borg M, Thastrup T, Larsen KL, Overgaard K, Hilberg O, Lokke A. Free diving-inspired breathing techniques for COPD patients: A pilot study. Chron Respir Dis. 2021 Jan-Dec;18:14799731211038673. doi: 10.1177/14799731211038673.
PubMed 34399604
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Free Diving Breathing Training on Symptoms in Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT07455968
- Acronym / sponsor ID
- Ex Physio SPSC 12
- Conditions
- Allergic Rhinitis
- Keywords
- Free diving breathing, Allergic rhinitis, Rhinitis symptoms, Pulmonary function, Respiratory muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 6 Mar 2026 (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.
The purpose of this study was to investigate the effects of diver-style breathing training on symptoms, pulmonary function, and respiratory muscle, in patients with allergic rhinitis.
Detailed description
This study aims to investigate the effects of diver-style breathing training in patients with allergic rhinitis. A total of 30 patients aged 18-35 years were recruited from students and staff of Chulalongkorn University, as well as patients attending the Chulalongkorn University Health Service Center and King Chulalongkorn Memorial Hospital. Participants were randomly assigned into two groups: an experimental group (n = 15) that received diver-style breathing training and a control group (n = 15) that continued their usual daily activities without any exercise intervention.
The independent variable was diver-style breathing training. The dependent variables included rhinitis symptom outcomes (symptom scores, Peak Nasal Inspiratory Flow, nasal blood flow, and Fractional Exhaled Nitric Oxide), pulmonary function parameters (FVC, FEV1, FEV1/FVC, FEF25-75%, MVV, and breath-holding time), and respiratory muscle strength (MIP and MEP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free diving breathing training | Experimental | Other: Free diving breathing training |
| Control group (Normal daily life) | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients diagnosed with persistent allergic rhinitis (allergen of any type), both male and female, presenting with nasal congestion, sneezing, nasal itching, and rhinorrhea occurring more than 4 days per week, with an average symptom score greater than 7. Eligibility was determined using the Rhinitis Symptoms Score (0, 1, 2, and ≥3 scale) assessed over the previous week and on the day of testing. Participants must not have any complications such as sinusitis, Eustachian tube dysfunction, or asthma.
- No history of other respiratory diseases, including bronchitis, pertussis, pneumonia, pneumonitis, pulmonary aspergilloma, tuberculosis, asthma, lung cancer, emphysema, or other related conditions.
- No regular exercise training exceeding 20 minutes per session, 3 days per week or more, during the 6 months prior to participation.
- No regular consumption of vitamin supplements or herbal products at least 3 days per week during the 6 months prior to participation.
- Ability to discontinue the following medications before and during the study period: Antihistamines for at least 3 days, Oral steroids and nasal steroids for at least 2 weeks, Leukotriene receptor antagonists for at least 1 week
Key exclusion criteria (5 listed)
- Inability to continue participation due to unforeseen circumstances, such as injury or illness.
- Absence from more than 8 training sessions out of a total of 40 sessions.
- Withdrawal of consent or unwillingness to continue participation.
- Inability to discontinue medications according to the specified criteria.
- Exacerbation of allergic rhinitis symptoms that prevents continued participation, such as persistent rhinorrhea or severe nasal congestion causing difficulty breathing.
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 |
|---|---|---|
| Free diving breathing trainingThe diver-style breathing training program lasts 40 minutes per session. Participants sit upright with proper posture and begin with 5 minutes of normal breathing. They then perform a progressive deep inhalation technique: inhaling through the nose to expand the abdomen, continuing to expand the chest, and finally inhaling further until a sensation of throat tightness is felt. The breath is then held for at least 20 seconds or as long as possible before exhaling through the mouth. Each cycle counts as one round, and participants aim to gradually increase their breath-holding duration over 30 minutes. The session ends with 5 minutes of normal breathing. | Other | Free diving breathing training |
Primary outcome
Rhinitis symptom scores
Time frame: Change from Baseline Rhinitis symptom scores at 8 weeks.
Nasal symptoms were assessed using Total Nasal Symptom Score (TNSS) questionnaire. The subjects were asked to score symptoms of persistent allergic rhinitis before and after yoga training protocol. The total nasal symptom scores were computed as the sum of four individual nasal symptom scores; nasal congestion, itching, sneezing, and rhinorrhea. The scores ranged from 0 to 3 scale (0=none, 1=mild, 2=moderate, 3= severe)
Peak nasal inspiratory flow; PNIF
Time frame: Change from Baseline respiratory muscle strength at 8 weeks.
Participants were instructed to inhale through the device as quickly and forcefully as possible using a Peak Nasal Inspiratory Flow (PNIF) meter.
Nasal blood flow
Time frame: Change from Baseline Rhinitis symptom scores at 8 weeks.
Laser Doppler flowmetry (DRT4, Moor Instruments, UK) was used to measure the NBF. Before the test, each subject rested for 1 hour in a separate room. During the test, the participants were instructed to breathe normally and not to speak, cough, or move. A lateral endoscopic probe with a flexible 1.34-mm-diameter flexible nylon sheath was placed on the front of the nose.
Fractional Exhaled Nitric Oxide Testing; FeNO
Time frame: Change from Baseline Rhinitis symptom scores at 8 weeks.
FeNO Monitor (BedFont, UK) was used to measure the FeNO. The participants inhaled deeply for 2 to 3 seconds before exhaling slowly, which normally took 10 seconds.
7 secondary outcomes
Forced Vital Capacity; FVC
Time frame: Change from Baseline respiratory muscle strength at 8 weeks.
Forced Expiratory Volume in one second; FEV1
Time frame: Change from Baseline respiratory muscle strength at 8 weeks.
Forced Expiratory Flow at 25-75% of FVC; FEF25 - 75 %
Time frame: Change from Baseline respiratory muscle strength at 8 weeks.
Maximum Voluntary Ventilation; MVV
Time frame: Change from Baseline respiratory muscle strength at 8 weeks.
Breath Holding Time Test
Time frame: Change from Baseline respiratory muscle strength at 8 weeks.
Maximal Inspiratory Pressure; MIP
Time frame: Change from Baseline respiratory muscle strength at 8 weeks.
Maximal expiratory pressure; MEP
Time frame: Change from Baseline respiratory muscle strength at 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 23487544Ostrowski A, Strzala M, Stanula A, Juszkiewicz M, Pilch W, Maszczyk A. The role of training in the development of adaptive mechanisms in freedivers. J Hum Kinet. 2012 May;32:197-210. doi: 10.2478/v10078-012-0036-2. Epub 2012 May 30.
- Background: PubMed 30584292Leelarungrayub J, Puntumetakul R, Sriboonreung T, Pothasak Y, Klaphajone J. Preliminary study: comparative effects of lung volume therapy between slow and fast deep-breathing techniques on pulmonary function, respiratory muscle strength, oxidative stress, cytokines, 6-minute walking distance, and quality of life in persons with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 5;13:3909-3921. doi: 10.2147/COPD.S181428. eCollection 2018.
- Background: PubMed 25505949Desai MB, Gavrilova T, Liu J, Patel SA, Kartan S, Greco SJ, Capitle E, Rameshwar P. Pollen-induced antigen presentation by mesenchymal stem cells and T cells from allergic rhinitis. Clin Transl Immunology. 2013 Oct 18;2(10):e7. doi: 10.1038/cti.2013.9. eCollection 2013 Oct.
- Background: PubMed 24700159Diniz CM, Farias TL, Pereira MC, Pires CB, Goncalves LS, Coertjens PC, Coertjens M. Chronic adaptations of lung function in breath-hold diving fishermen. Int J Occup Med Environ Health. 2014 Apr;27(2):216-23. doi: 10.2478/s13382-014-0259-7. Epub 2014 Apr 3.
- Background: PubMed 29103802Dykewicz MS, Wallace DV, Baroody F, Bernstein J, Craig T, Finegold I, Huang F, Larenas-Linnemann D, Meltzer E, Steven G, Bernstein DI, Blessing-Moore J, Dinakar C, Greenhawt M, Horner CC, Khan DA, Lang D, Oppenheimer J, Portnoy JM, Randolph CR, Rank MA; Workgroup Chair and Cochair; Dykewicz MS, Wallace DV. Treatment of seasonal allergic rhinitis: An evidence-based focused 2017 guideline update. Ann Allergy Asthma Immunol. 2017 Dec;119(6):489-511.e41. doi: 10.1016/j.anai.2017.08.012. Epub 2017 Nov 2. No abstract available.
- Background: PubMed 34399604Borg M, Thastrup T, Larsen KL, Overgaard K, Hilberg O, Lokke A. Free diving-inspired breathing techniques for COPD patients: A pilot study. Chron Respir Dis. 2021 Jan-Dec;18:14799731211038673. doi: 10.1177/14799731211038673.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free diving breathing training in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 8 Oct 2026. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinitis symptom scores (time frame: Change from Baseline Rhinitis symptom scores at 8 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07455968, which also lists 6 linked publications.
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 8 Oct 2026.