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Sleep Apnea in Asthmatic Children and Teenagers

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ClinicalTrials.gov Identifier: NCT03034447
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Associação Fundo de Incentivo à Pesquisa
Information provided by (Responsible Party):
Gustavo Antonio Moreira, Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Asthma, Bronchial Bronchial Asthma Apnea, Sleep Sleep Apnea, Mixed Central and Obstructive Sleep Hypopnea (Diagnosis) Obstructive Sleep Apnea Obstructive Sleep Apnea Syndrome Other: Questionnaire Other: Lung Function Test Other: Home Sleep Study Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Sleep study and spirometric evaluation of children with asthma
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Obstructive Sleep Apnea in Asthmatic Children: Does the Sex Matter?
Study Start Date : December 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Sleep Apnea

Arm Intervention/treatment
Asthma
Children and teenagers with persistent asthma will perform questionnaires, lung function test, and home sleep study
Other: 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

Other: Lung Function Test
Children are going to blow in a machine that measures how the lung is working
Other Name: Spirometry

Other: Home Sleep Study
Children are going to sleep at home with a device that tells if they stop breathing during sleep
Other Name: Polysomnography




Primary Outcome Measures :
  1. Sleep Apnea Syndrome [ Time Frame: 1 night ]
    Apneas and hypopneas during sleep


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent asthma

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034447


Locations
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Brazil
Federal University of São Paulo
São Paulo, Brazil, 04021-001
Sponsors and Collaborators
Federal University of São Paulo
Associação Fundo de Incentivo à Pesquisa
Investigators
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Study Chair: Gustavo A Moreira, MD Federal University of São Paulo

Publications:
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Responsible Party: Gustavo Antonio Moreira, Medical Doctor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03034447     History of Changes
Other Study ID Numbers: CEP/UNIFESP 1398/2016
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gustavo Antonio Moreira, Federal University of São Paulo:
Asthma
Obstructive Sleep Apnea
Children
Teenagers

Additional relevant MeSH terms:
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Asthma
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases