AsthmaNCT02724657
Buteyko Method for Asthmatic Children With Mouth Breathing
A study testing Buteyko Method in people with Asthma and Mouth Breathing, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of asthmatic children with mouth breathing. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Asthma, Mouth Breathing
- What is being tested?
- Buteyko Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Oct 2016
- Phase
- Interventional
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 7 up to 12 years old with asthma diagnose
- Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks.
- Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, and tuberculosis), retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.
Who cannot join
- Children that are not able to perform some of the necessary procedures, give up participating in the research and present acute symptoms of respiratory tract during the assessments.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Norte (UFRN)
Natal, Rio Grande do Norte, 59078970
About this study
Official title: THE EFFECTS OF THE BUTEYKO METHOD IN MOUTH BREATHING ASTHMATIC CHILDREN: A CONTROLLED RANDOMIZED STUDY
To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of asthmatic children with mouth breathing.
- Conditions
- Asthma, Mouth Breathing
- Being tested
- Buteyko Method
- Keywords
- Child, Breathing exercises
- Medical subject headings
- Asthma, Mouth Breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buteyko MethodOther
Intervention will be held twice a week during 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Buteyko Method | Experimental | Children will perform 6 sessions (twice a week) of treatment with the Buteyko Method. Receives: Other: Buteyko Method |
| Control | No intervention | Asthma education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep disturbance (questionnaire)
Sleep disturbance will be assessed by the sleep disturbance scale for children (SDSC).
Measured: Baseline, three weeks later and six months after treatment
Secondary outcomes (4)
Change in spirometry (FVC, FEV1, FEV1/FVC, FEF25-75%, PEF)
Measured: Baseline, three weeks later and six months after treatment
Change in ventilometry (minute volume and vital capacity)
Minute volume and vital capacity (liters)
Measured: Baseline, three weeks later and six months after treatment
Number of hospitalizations
Measured: Through study completion, an average of three weeks and six months after treatment
Number of days off-school
Measured: During the three weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724657
- Sponsor's protocol ID
- 1.443.588
- Status last verified
- Jan 2017
- First submitted
- 7 Mar 2016
- Last updated
- 24 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF THE BUTEYKO METHOD IN MOUTH BREATHING ASTHMATIC CHILDREN: A CONTROLLED RANDOMIZED STUDY
- ClinicalTrials.gov ID
- NCT02724657
- Acronym / sponsor ID
- 1.443.588
- Conditions
- Asthma, Mouth Breathing
- Keywords
- Child, Breathing exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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.
To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of asthmatic children with mouth breathing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buteyko Method | Experimental | Other: Buteyko MethodChildren will perform 6 sessions (twice a week) of treatment with the Buteyko Method. |
| Control | No intervention | –Asthma education. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children from 7 up to 12 years old with asthma diagnose
- Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks.
- Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, and tuberculosis), retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.
Key exclusion criteria (1 listed)
- Children that are not able to perform some of the necessary procedures, give up participating in the research and present acute symptoms of respiratory tract during the assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buteyko MethodIntervention will be held twice a week during 3 weeks. | Other | Buteyko Method |
Primary outcome
Change in Sleep disturbance (questionnaire)
Time frame: Baseline, three weeks later and six months after treatment
Sleep disturbance will be assessed by the sleep disturbance scale for children (SDSC).
4 secondary outcomes
Change in spirometry (FVC, FEV1, FEV1/FVC, FEF25-75%, PEF)
Time frame: Baseline, three weeks later and six months after treatment
Change in ventilometry (minute volume and vital capacity)
Time frame: Baseline, three weeks later and six months after treatment
Number of hospitalizations
Time frame: Through study completion, an average of three weeks and six months after treatment
Number of days off-school
Time frame: During the three weeks of treatment
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 24 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buteyko Method in people with Asthma and Mouth Breathing, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 3 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 24 Jan 2017. 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 Brazil. 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?
Change in Sleep disturbance (questionnaire) (time frame: Baseline, three weeks later and six months after treatment). 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 24 Jan 2017.