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Effect of the Nasal Provocation on the Breathing Style

Effect of the Nasal Provocation on the Breathing Style and on the Calibration of Respiratory Effort Belts

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02146300
Enrollment
30
Registered
2014-05-23
Start date
2014-03-31
Completion date
2016-06-30
Last updated
2014-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birch Pollen Allergy, Healthy Control Subjects

Keywords

birch pollen, allergy, breathing, pattern, exposure

Brief summary

The purpose of this study is to find out how the provocation of the nose changes breathing style (specifically, frequency and tidal volume changes)

Detailed description

It is intended to clarify on both healthy and birch pollen allergic adults how the provocation of the nose with the birch pollen, dilutant and xylometazoline affect the breathing style (breathing pattern) and how these possible changes could be controlled in the measurement of the breathing with respiratory effort belts. In addition to this, our intention is to clarify the effect of the facial mask on the breathing. The allergic and control subjects undergo nasal provocation in 2 sessions. The first is done with birch pollen extract (should block the nose in allergic subjects) and the second with xylometazoline (should open the nose). The mask group undergo similar measurements without nasal exposures. The second objective of the study is to clarify if there are differences between the allergic and control subjects in the function of the autonomous nervous system during these provocations. This is done with the heart rate variability analysis method.

Interventions

BIOLOGICAL1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure

Aquagen SQ 10 000 SQ/ml nasal exposure Xylometazoline 1 mg/ml nasal exposure

Sponsors

Oulu University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Birch pollen allergic subjects must have clear nasal symptoms during the birch pollen season and birch specific IgE \>= 0.70 * Healthy subjects: birch specific IgE \< 0.35 * The subjects are not allowed to be under medication that affects the function of their nose during a specific time period before the measurement * They have to be free of any acute respiratory symptoms during the prior two weeks to the measurements * Before measurement, they are not allowed to have heavy meal or sport * They are not allowed to have caffeine or other stimulants for 12 hours or alcohol for 24 hours.

Exclusion criteria

* Heart diseases * Brain circulatory disorders * Surgical operations of nose * Chronic nasal symptoms * Pregnancy * Smoker

Design outcomes

Primary

MeasureTime frameDescription
breathing stylecontinuously during 2 hoursfrequence and volume of breathing measured with spirometry and respiratory effort belts

Secondary

MeasureTime frameDescription
thorax - abdomen relationcontinuously during 2 hoursrelation of the movements of the thorax and abdomen as measured with the respiratory belts
activation of the autonomous nervous systemcontinuously during 2 hoursactivity of the autonomous nervous system as measured with heart rate variability

Countries

Finland

Contacts

Primary ContactTiina Seppänen, MSc
tiina.seppanen@oulu.fi+358294488028
Backup ContactOlli-Pekka Alho, Professor
olli-pekka.alho@oulu.fi+35883153473

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026