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Sleep Apnea in Asthmatic Children and Teenagers

Obstructive Sleep Apnea in Asthmatic Children: Does the Sex Matter?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03034447
Enrollment
80
Registered
2017-01-27
Start date
2016-12-31
Completion date
2018-09-30
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchial, Bronchial Asthma, Apnea, Sleep, Sleep Apnea, Mixed Central and Obstructive, Sleep Hypopnea (Diagnosis), Obstructive Sleep Apnea, Obstructive Sleep Apnea Syndrome

Keywords

Asthma, Obstructive Sleep Apnea, Children, Teenagers

Brief summary

Asthma and sleep apnea are both respiratory diseases and one can worsen the other. Those who suffer from asthma have a higher risk of sleep apnea and sleep apnea can make the asthma more difficult to control. 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.

Detailed description

Obstructive sleep apnea (OSA) and asthma are both inflammatory airway diseases. A systematic review regarding sleep-disordered breathing (SDB) in asthmatic children analyzed 17 studies but only two of them had objective OSA measurement. In total, 45,115 children were included, 53% boys, mean age 8.6 ± 2.5 years. SDB was present in 23.8% of asthmatic children and in 16.7% of non-asthmatic (p \< 0.001, OR 1.9, 95%CI 1.7-2.2). 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.

Interventions

OTHERQuestionnaire

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

Children are going to blow in a machine that measures how the lung is working

Children are going to sleep at home with a device that tells if they stop breathing during sleep

Sponsors

Associação Fundo de Incentivo à Pesquisa
CollaboratorOTHER
Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Sleep study and spirometric evaluation of children with asthma

Eligibility

Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Persistent asthma

Exclusion criteria

* Craniofacial malformation * Thoracic malformation * Genetic syndromes * Bronchopulmonary dysplasia * Bronchiolitis obliterans * Neuromuscular diseases * Sickle cell anemia * Cystic fibrosis

Design outcomes

Primary

MeasureTime frameDescription
Sleep Apnea Syndrome1 nightApneas and hypopneas during sleep

Secondary

MeasureTime frameDescription
Asthma Control4 weeksAsthma Control based on Global Initiative for Asthma (GINA) questions
ER visits1 yearHow many times went to hospital the previous year
Lung function1 dayCurrently lung function

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026