Effect of Mouth Breathing on Exercise Induced Bronchoconstriction.

The Effect of Mouth Breathing on Exercise Induced Bronchoconstriction in Children.

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Diagnostic test: Exercise challenge test (ECT)

Detailed Description

Introduction: Exercise induced bronchoconstriction (EIB) is a common finding in the pediatric population with and without asthma. EIB is evaluated with serial measurements of lung functions during exercise protocol. 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 exercise induced bronchoconstriction.

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, during 2020-2021. Children referred for ECT will be registered to the study after signing an informed consent and will be evaluated in two separate visits. Visit 1 - ECT with a nose clip and visit 2 - ECT without a nose clip. ECT will be conducted according to the institute protocol, based on American Thoracic Society (ATS) guidelines. 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Lea Bentur, MD; Phone Number: +97244360; Email: l_bentur@rambam.health.gov.il
• Study Contact Backup: Name: Ronen Bar-Yoseph, MD; Phone Number: +97247774360; Email: r_bar-yoseph@rambam.health.gov.il

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam Medical Center
    • Contact: Ronen Bar-Yoseph, MD; Phone Number: +97247774360; Email: r_bar-yoseph@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children and adolescences (6-18 years old) referred to perform exercise challenge test as a part of exercise induced asthma evaluation.

Description

Inclusion Criteria:

• Exercise challenge test as part of exercise induced asthma evaluation.
• Age 6-18 years.

Exclusion Criteria:

• Other chronic lung disease
• Significant background illness
• Severe asthma exacerbation or systemic steroids - last 2 months
• Persistent use of inhaled steroids - last 2 weeks
• Use of short acting bronchodilators - last 24 hours.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Exercise challenge test (ECT) with and without nose clip (NC).; All participants after receiving informed consent were invited for 2 visits. Visit 1 - ECT performed with NC. Visit 2 - ECT performed without NC. Demographic and clinical data and measurements of vital signs, exercise data and lung functions were recorded. ECT completed on treadmill. Questionnaires: Total Nasal Symptom Score (TNSS 0-6). Asthma Control Test (ACT 5-25) . Positive ECT = drop in FEV1 >12% from baseline

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary end point	Maximum drop of forced expiratory volume in one second - (FEV1) after exercise challenge test with and without Nose clip.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary end point	Forced expiratory volume in one second - (FEV1) improvement after bronchodilators during exercise challenge test with and without Nose clip	15 minutes

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Lea Bentur, MD, Rambam Medical Center Haifa, Israel.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Mouth Breathing
• Other Study ID Numbers: 0716-19-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No