NCT07455968

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

Free diving breathingAllergic rhinitisRhinitis symptomsPulmonary functionRespiratory muscle strength

Outcome Measures

Primary Outcomes (4)

  • 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)

    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.

    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.

    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.

    Change from Baseline Rhinitis symptom scores at 8 weeks.

Secondary Outcomes (7)

  • Forced Vital Capacity; FVC

    Change from Baseline respiratory muscle strength at 8 weeks.

  • Forced Expiratory Volume in one second; FEV1

    Change from Baseline respiratory muscle strength at 8 weeks.

  • Forced Expiratory Flow at 25-75% of FVC; FEF25 - 75 %

    Change from Baseline respiratory muscle strength at 8 weeks.

  • Maximum Voluntary Ventilation; MVV

    Change from Baseline respiratory muscle strength at 8 weeks.

  • Breath Holding Time Test

    Change from Baseline respiratory muscle strength at 8 weeks.

  • +2 more secondary outcomes

Study Arms (2)

Free diving breathing training

EXPERIMENTAL
Other: Free diving breathing training

Control group (Normal daily life)

NO INTERVENTION

Interventions

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.

Free diving breathing training

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (6)

  • 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.

    PMID: 23487544BACKGROUND
  • Leelarungrayub 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.

    PMID: 30584292BACKGROUND
  • Desai 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.

    PMID: 25505949BACKGROUND
  • Diniz 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.

    PMID: 24700159BACKGROUND
  • Dykewicz 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.

    PMID: 29103802BACKGROUND
  • Borg 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.

    PMID: 34399604BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 6, 2026

Study Start

August 1, 2025

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations