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Completed

NCT Number: NCT04734795

The Prevalence of Dysfunctional Breathing in Children and Adolescents With Asthma

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.

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Key information

Conditions

Dysfunctional Breathing Asthma Asthma in Children Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kolding Sygehus

Kolding, 6000, Denmark

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Mask score

    Time frame: 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)

    Time frame: 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

    Time frame: 1 year

    Age in years of study subjects

  4. Sex

    Time frame: 1 year

    Sex of study subjects

  5. Standardised body mass index (BMI_SDS)

    Time frame: 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

    Time frame: 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%)

    Time frame: 1 year

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

  8. Method of asthma diagnose

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kolding Sygehus

Other

Collaborators

  • Odense Patient Data Explorative Network

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2021
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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