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Completed

NCT Number: NCT03034447

Sleep Apnea in Asthmatic Children and Teenagers

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.

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Key information

Conditions

Asthma, Bronchial Apnea Apnea, Sleep Asthma Bronchial Asthma Bronchial Diseases Disease Dyssomnias Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Obstructive Sleep Apnea Obstructive Sleep Apnea Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Mixed Central and Obstructive Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Hypopnea (Diagnosis) Sleep Wake Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Paulo

São Paulo, 04021-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persistent asthma

Exclusion criteria

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

Treatment and study plan

Questionnaire

Other

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

Other

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

Other names: Spirometry

Home Sleep Study

Other

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

Other names: Polysomnography

Primary outcomes

  1. Sleep Apnea Syndrome

    Time frame: 1 night

    Apneas and hypopneas during sleep

Secondary outcomes

  1. Asthma Control

    Time frame: 4 weeks

    Asthma Control based on Global Initiative for Asthma (GINA) questions

  2. ER visits

    Time frame: 1 year

    How many times went to hospital the previous year

  3. Lung function

    Time frame: 1 day

    Currently lung function

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Associação Fundo de Incentivo à Pesquisa

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 27, 2017
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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