Dysfunctional BreathingNCT04734795
The Prevalence of Dysfunctional Breathing in Children and Adolescents With Asthma
An observational study of Dysfunctional Breathing and Asthma in Children, run by Kolding Sygehus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Dysfunctional Breathing, Asthma in Children, Asthma
- How many people
- 363 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Feb 2021to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Child
Study population: Children and adolecents with asthma in a hospital outpatient clinic
Who may be able to join
- Asthma diagnosed by lung function tests and/or typical symptoms.
- Treatment with inhaled corticosteroids in minimum 3 months.
Who cannot join
- Other significant cardiopulmonary or muscoluskeletal conditions.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dysfunctional Breathing, Asthma in Children, Asthma
- Keywords
- Dysfunctional breathing, Asthma in children, Asthma in adolescents
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of children with dysfunctional breathing defined as Nijmegen Questionnaire ( NQ) Score >= 23
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.
Measured: 1 year
Secondary outcomes (8)
Mask score
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
Measured: 1 year
Asthma Control Questionnaire ( ACQ5)
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.
Measured: 1 year
Age
Age in years of study subjects
Measured: 1 year
Sex
Sex of study subjects
Measured: 1 year
Standardised body mass index (BMI_SDS)
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)
Measured: 1 year
The reported use of rescue Beta2 agonist in puffs per week
The reported use of short acting beta 2 agonist in puffs per week the last week.
Measured: 1 year
Forced expiratory volume inthe first second in percent of expected Value. ( FEV1%)
Spirometry is performed according to guidelines. FEV1% is calculated by the spirometry software.
Measured: 1 year
Method of asthma diagnose
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start5 Feb 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Responsible party
- Principal investigator, Signe Vahlkvist, Kolding Sygehus
- Investigators
- Signe Vahlkvist, Principal investigator, Kolding Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734795
- Sponsor's protocol ID
- S-2020-0101-a
- Status last verified
- Oct 2022
- First submitted
- 21 Jan 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie published results, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Dysfunctional Breathing in Children and Adolescents With Asthma
- ClinicalTrials.gov ID
- NCT04734795
- Acronym / sponsor ID
- S-2020-0101-a
- Conditions
- Dysfunctional Breathing, Asthma in Children, Asthma
- Keywords
- Dysfunctional breathing, Asthma in children, Asthma in adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Kolding SygehusUniversity, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Children and adolecents with asthma in a hospital outpatient clinic
Key inclusion criteria (2 listed)
- Asthma diagnosed by lung function tests and/or typical symptoms.
- Treatment with inhaled corticosteroids in minimum 3 months.
Key exclusion criteria (1 listed)
- Other significant cardiopulmonary or muscoluskeletal conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Mask score
Time frame: 1 year
Asthma Control Questionnaire ( ACQ5)
Time frame: 1 year
Age
Time frame: 1 year
Sex
Time frame: 1 year
Standardised body mass index (BMI_SDS)
Time frame: 1 year
The reported use of rescue Beta2 agonist in puffs per week
Time frame: 1 year
Forced expiratory volume inthe first second in percent of expected Value. ( FEV1%)
Time frame: 1 year
Method of asthma diagnose
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie published results, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Signe Vahlkvist principal investigator
Kolding Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysfunctional Breathing and Asthma in Children, run by Kolding Sygehus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of children with dysfunctional breathing defined as Nijmegen Questionnaire ( NQ) Score >= 23 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.