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Effect of Mouth Breathing on Exercise Induced Bronchoconstriction.

NCT05376436 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-05-17

No results posted yet for this study

Summary

Introduction: Exercise induced bronchoconstriction (EIB) is a common finding in the pediatric population with and without asthma. EIB is suspected with a drop of 10-15% in Forced expiratory volume in the 1st second (FEV1) during exercise challenge test (ECT). Some researchers assume that oral breathing, in several mechanisms, increase hyper-responsiveness of the airways.

Aim: Asses the effect of a nose clip and allergic rhinitis in EIB. Hypothesis: The use of a nose clip in exercise challenges will increase the rate of positive tests. However, we assume that children with symptomatic allergic rhinitis will not demonstrate similar trends.

Methods: A prospective, single center cohort study in a pediatric pulmonology institute, at Ruth's children hospital, Rambam medical center, Haifa, Israel. Children referred for ECT will be registered to the study and will be evaluated in two separate visits. Visit 1 - ECT with a nose clip and visit 2 - ECT without a nose clip. Demographic and clinical data and measurements of serial vital signs, exercise data and lung functions will be taken, as well as Total Nasal Symptoms Score (TNSS) and Asthma Control Test (ACT) questionnaires.

Conditions

  • Asthma in Children

Interventions

DIAGNOSTIC_TEST

Exercise challenge test (ECT)

Baseline demographic, clinical and rest lung functions were recorded. ECT was performed on treadmill according to fixed protocol. Clinical data during ECT was recorded. (visit 1- performed with nose clip, visit 2- performed without nose clip). Lung function were measured and recorded at fixed time after ECT and after bronchodilator administration.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Lea Bentur, MD · Rambam Medical Center Haifa, Israel.

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05376436 on ClinicalTrials.gov