Sleep Apnea in Asthmatic Children and Teenagers

February 14, 2019 updated by: Gustavo Antonio Moreira, Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04021-001
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persistent asthma

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Spirometry
Other: Home Sleep Study
Children are going to sleep at home with a device that tells if they stop breathing during sleep
Other Names:
  • Polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Apnea Syndrome
Time Frame: 1 night
Apneas and hypopneas during sleep
1 night

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control
Time Frame: 4 weeks
Asthma Control based on Global Initiative for Asthma (GINA) questions
4 weeks
ER visits
Time Frame: 1 year
How many times went to hospital the previous year
1 year
Lung function
Time Frame: 1 day
Currently lung function
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Associação Fundo de Incentivo à Pesquisa

Investigators

  • Study Chair: Gustavo A Moreira, MD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP/UNIFESP 1398/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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