Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2016-12-31
2018-09-30
Brief Summary
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As girls usually have a more severe asthma than boys, the investigators believe that girls have a higher risk of sleep apnea.
To test if asthmatic girls have more sleep apnea than boys, the investigators are going to ask them questions regarding asthma and sleep symptoms (such as snore) and the investigators are going test the lung function and how many times they stop breathing during the sleep. The sleep test is going to be performed in children's home.
In children, having sleep apnea can make the asthmatic stay in the hospital 30% more when they have an asthma attack. We also are going to look if sleep apnea increases the number of hospitalizations and asthma attacks in the past 12 months.
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Detailed Description
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An American study found that OSA in asthmatic children increases hospital length of stay (OR 2.3; 95% CI = 1.8 - 2.9). Brazilian database of the year 2015 showed that, among children 5-19 years, asthma was the 5th cause of hospitalization: a total of 2.4% of the hospitalization in this age group, after birth and its complication (31%), limb fractures (5.7%), pneumonia (3.8%), and appendicitis (3.2%).
The relationship among asthma severity (mild, moderate, and severe) and OSA has been described previously, but not in every study. Poor asthma control has also been linked to a higher OSA risk in adults and children.
OSA and asthma share many risk factors: rhinitis, increased collapsibility of the upper airway, local and systemic inflammation, gastroesophageal reflux, and obesity.
A higher risk of SDB in asthmatic girls has recently been described (OR 2.55 for girls and 0.70 for boys). Among non-asthmatic children OSA is usually equal among boys and girls until adolescence. A possible explanation is asthma severity in children: younger boys are more severe but after puberty, girls are.
Since OSA and asthma are linked diseases and that little is known about them in the pediatric field, specially differences related to sex, the investigators hypothesize that: 1) asthmatic girls have a higher OSA risk; 2) OSA will be higher in asthmatic children compared to the pediatric literature; 3) asthma severity, asthma control, and rhinitis will be related to a higher OSA risk. The investigators also aim to analyze factors associated with a higher risk of hospitalizations and asthma attacks.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Asthma
Children and teenagers with persistent asthma will perform questionnaires, lung function test, and home sleep study
Questionnaire
Children and parents are going to inform data regarding socioeconomical status, asthma and rhinitis diagnosis, asthma and rhinitis control, medications, sleep complaints, and sleep habits
Lung Function Test
Children are going to blow in a machine that measures how the lung is working
Home Sleep Study
Children are going to sleep at home with a device that tells if they stop breathing during sleep
Interventions
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Questionnaire
Children and parents are going to inform data regarding socioeconomical status, asthma and rhinitis diagnosis, asthma and rhinitis control, medications, sleep complaints, and sleep habits
Lung Function Test
Children are going to blow in a machine that measures how the lung is working
Home Sleep Study
Children are going to sleep at home with a device that tells if they stop breathing during sleep
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Thoracic malformation
* Genetic syndromes
* Bronchopulmonary dysplasia
* Bronchiolitis obliterans
* Neuromuscular diseases
* Sickle cell anemia
* Cystic fibrosis
7 Years
17 Years
ALL
No
Sponsors
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Associação Fundo de Incentivo à Pesquisa
OTHER
Federal University of São Paulo
OTHER
Responsible Party
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Gustavo Antonio Moreira
Medical Doctor
Principal Investigators
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Gustavo A Moreira, MD
Role: STUDY_CHAIR
Federal University of São Paulo
Locations
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Federal University of São Paulo
São Paulo, , Brazil
Countries
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References
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Malakasioti G, Gourgoulianis K, Chrousos G, Kaditis A. Interactions of obstructive sleep-disordered breathing with recurrent wheezing or asthma and their effects on sleep quality. Pediatr Pulmonol. 2011 Nov;46(11):1047-54. doi: 10.1002/ppul.21497. Epub 2011 Aug 1.
Kheirandish-Gozal L, Dayyat EA, Eid NS, Morton RL, Gozal D. Obstructive sleep apnea in poorly controlled asthmatic children: effect of adenotonsillectomy. Pediatr Pulmonol. 2011 Sep;46(9):913-8. doi: 10.1002/ppul.21451. Epub 2011 Apr 4.
Alonso-Alvarez ML, Teran-Santos J, Ordax Carbajo E, Cordero-Guevara JA, Navazo-Eguia AI, Kheirandish-Gozal L, Gozal D. Reliability of home respiratory polygraphy for the diagnosis of sleep apnea in children. Chest. 2015 Apr;147(4):1020-1028. doi: 10.1378/chest.14-1959.
Shanley LA, Lin H, Flores G. Factors associated with length of stay for pediatric asthma hospitalizations. J Asthma. 2015 Jun;52(5):471-7. doi: 10.3109/02770903.2014.984843. Epub 2014 Nov 21.
Goldstein NA, Aronin C, Kantrowitz B, Hershcopf R, Fishkin S, Lee H, Weaver DE, Yip C, Liaw C, Saadia TA, Abramowitz J, Weedon J. The prevalence of sleep-disordered breathing in children with asthma and its behavioral effects. Pediatr Pulmonol. 2015 Nov;50(11):1128-36. doi: 10.1002/ppul.23120. Epub 2014 Dec 2.
Other Identifiers
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CEP/UNIFESP 1398/2016
Identifier Type: -
Identifier Source: org_study_id
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