Buteyko Method for Asthmatic Children With Mouth Breathing

Asthma Clinical Trial

Official title:

THE EFFECTS OF THE BUTEYKO METHOD IN MOUTH BREATHING ASTHMATIC CHILDREN: A CONTROLLED RANDOMIZED STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724657
• Other study ID #: 1.443.588
• Status: Completed
• Phase: N/A
• First received: March 7, 2016
• Last updated: January 20, 2017
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of asthmatic children with mouth breathing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Asthma
• Mouth Breathing
• Respiratory Aspiration

Intervention

Other:
• Buteyko Method
Intervention will be held twice a week during 3 weeks.

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Norte (UFRN)	Natal	Rio Grande do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sleep disturbance (questionnaire)	Sleep disturbance will be assessed by the sleep disturbance scale for children (SDSC).	Baseline, three weeks later and six months after treatment
Secondary	Change in spirometry (FVC, FEV1, FEV1/FVC, FEF25-75%, PEF)		Baseline, three weeks later and six months after treatment
Secondary	Change in ventilometry (minute volume and vital capacity)	Minute volume and vital capacity (liters)	Baseline, three weeks later and six months after treatment
Secondary	Number of hospitalizations		Through study completion, an average of three weeks and six months after treatment
Secondary	Number of days off-school		During the three weeks of treatment