The Prevalence of Dysfunctional Breathing in Children and Adolescents With Asthma

Sponsor
Kolding Sygehus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04734795
Collaborator
Odense Patient Data Explorative Network (Other)
500
1
21.8
22.9

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate the prevalence of dysfunctional breathing in children and adolescents with asthma in a hospital outpatient clinic.

Participants are invited to take the Nijmegen Questionnaire and the Asthma Control Questionnaire. The prevalence of dysfunctional breathing defined as NQ score >= 23 is calculated, and demographics are compared between children with and without dysfunctional breathing.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of the study is to investigate the prevalence of dysfunctional breathing in children and adolecents with asthma in a hospital outpatient clinic.

    Participants are invited to take the Nijmegen Questionnaire and the Asthma Control Questionnaire, during appointments at the outpatient clinic. For this study purpose, each participant only takes the questionnairres once.

    Patient data regarding age, sex, asthma medication, lung function, allergic sensitization, method of asthma diagnose, Height, weight and Body mass index is registered from the electronical patient journal.

    The prevalence of dysfunctional breathing in the cohort is calculated as the fraction of children with a NQ score >= 23.

    The group of children and adolescents with dysfunctional breathing is characterized and compared to the group without dysfunctional breathing, regarding the descriptives mentioned above.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Prevalence of Dysfunctional Breathing in Children and Adolescents With Asthma
    Actual Study Start Date :
    Feb 5, 2021
    Actual Primary Completion Date :
    May 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of children with dysfunctional breathing defined as Nijmegen Questionnaire ( NQ) Score >= 23 [1 year]

      Nijmegen Questionnaire is a 16 point questionnairre addressing dysfunctional breathing. Each question is scored from 0 (best) to 4 (worst). NQ score is summarized between 0-64 points. NQ score >= 23 predicts dysfunctional breathing.

    Secondary Outcome Measures

    1. Mask score [1 year]

      Because of the ongoing COVID19 pandemic, face mask is acquired in public, and many children are homeschooled. We therefore generated an 8 question survey about the frequency of wearing mask, breathing difficulties while wearing a mask, and weather there is a lock down of school and sports while survey is taken. Questions are scored from 0-3 points, where 0 is Best and 3 is worst

    2. Asthma Control Questionnaire ( ACQ5) [1 year]

      ACQ5 contains 5 questions regarding asthma symptoms. Each question is scored between 0-6 points, where 0 represents very good asthma control and 6 represents poor asthma control. Total ACQ score is calculates as an average of points.

    3. Age [1 year]

      Age in years of study subjects

    4. Sex [1 year]

      Sex of study subjects

    5. Standardised body mass index (BMI_SDS) [1 year]

      Body mass index is calculated as weight ( kg)/ Height ( m) ^2. As BMI changes with age, BMI standard deviation BMI_SDS is calculated from Danish Reference Material : (Tinggaard J, Aksglaede L, Sørensen K, et al (2014) The 2014 Danish references from birth to 20 years for height, weight and body mass index. Acta Paediatr Int J Paediatr. doi: 10.1111/apa.12468)

    6. The reported use of rescue Beta2 agonist in puffs per week [1 year]

      The reported use of short acting beta 2 agonist in puffs per week the last week.

    7. Forced expiratory volume inthe first second in percent of expected Value. ( FEV1%) [1 year]

      Spirometry is performed according to guidelines. FEV1% is calculated by the spirometry software.

    8. Method of asthma diagnose [1 year]

      Fraction of subjects where asthma was diagnosed objectively from lung function variability (reversibility to beta2 agonist OR positive exercise challenge OR positive mannitol challenge). Method of asthma diagnose is noted from the electronical patient journal

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 17 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Asthma diagnosed by lung function tests and/or typical symptoms.

    • Treatment with inhaled corticosteroids in minimum 3 months.

    Exclusion Criteria:

    • Other significant cardiopulmonary or muscoluskeletal conditions.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kolding Sygehus Kolding Denmark 6000

    Sponsors and Collaborators

    • Kolding Sygehus
    • Odense Patient Data Explorative Network

    Investigators

    • Principal Investigator: Signe Vahlkvist, Kolding Sygehus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Signe Vahlkvist, Principal investigator, Kolding Sygehus
    ClinicalTrials.gov Identifier:
    NCT04734795
    Other Study ID Numbers:
    • S-2020-0101-a
    First Posted:
    Feb 2, 2021
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Signe Vahlkvist, Principal investigator, Kolding Sygehus
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 5, 2022