Sleep Apnea in Asthmatic Children and Teenagers
Primary Purpose
Asthma, Bronchial, Bronchial Asthma, Apnea, Sleep
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Questionnaire
Lung Function Test
Home Sleep Study
Sponsored by
About this trial
This is an interventional health services research trial for Asthma, Bronchial focused on measuring Asthma, Obstructive Sleep Apnea, Children, Teenagers
Eligibility Criteria
Inclusion Criteria:
- Persistent asthma
Exclusion Criteria:
- Craniofacial malformation
- Thoracic malformation
- Genetic syndromes
- Bronchopulmonary dysplasia
- Bronchiolitis obliterans
- Neuromuscular diseases
- Sickle cell anemia
- Cystic fibrosis
Sites / Locations
- Federal University of São Paulo
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Asthma
Arm Description
Children and teenagers with persistent asthma will perform questionnaires, lung function test, and home sleep study
Outcomes
Primary Outcome Measures
Sleep Apnea Syndrome
Apneas and hypopneas during sleep
Secondary Outcome Measures
Asthma Control
Asthma Control based on Global Initiative for Asthma (GINA) questions
ER visits
How many times went to hospital the previous year
Lung function
Currently lung function
Full Information
NCT ID
NCT03034447
First Posted
January 20, 2017
Last Updated
February 14, 2019
Sponsor
Federal University of São Paulo
Collaborators
Associação Fundo de Incentivo à Pesquisa
1. Study Identification
Unique Protocol Identification Number
NCT03034447
Brief Title
Sleep Apnea in Asthmatic Children and Teenagers
Official Title
Obstructive Sleep Apnea in Asthmatic Children: Does the Sex Matter?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Associação Fundo de Incentivo à Pesquisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Sleep study and spirometric evaluation of children with asthma
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asthma
Arm Type
Other
Arm Description
Children and teenagers with persistent asthma will perform questionnaires, lung function test, and home sleep study
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Lung Function Test
Other Intervention Name(s)
Spirometry
Intervention Description
Children are going to blow in a machine that measures how the lung is working
Intervention Type
Other
Intervention Name(s)
Home Sleep Study
Other Intervention Name(s)
Polysomnography
Intervention Description
Children are going to sleep at home with a device that tells if they stop breathing during sleep
Primary Outcome Measure Information:
Title
Sleep Apnea Syndrome
Description
Apneas and hypopneas during sleep
Time Frame
1 night
Secondary Outcome Measure Information:
Title
Asthma Control
Description
Asthma Control based on Global Initiative for Asthma (GINA) questions
Time Frame
4 weeks
Title
ER visits
Description
How many times went to hospital the previous year
Time Frame
1 year
Title
Lung function
Description
Currently lung function
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persistent asthma
Exclusion Criteria:
Craniofacial malformation
Thoracic malformation
Genetic syndromes
Bronchopulmonary dysplasia
Bronchiolitis obliterans
Neuromuscular diseases
Sickle cell anemia
Cystic fibrosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo A Moreira, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04021-001
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21809473
Citation
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.
Results Reference
background
PubMed Identifier
21465680
Citation
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.
Results Reference
background
PubMed Identifier
25539419
Citation
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.
Results Reference
background
PubMed Identifier
25375904
Citation
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.
Results Reference
background
PubMed Identifier
25461921
Citation
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.
Results Reference
background
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Sleep Apnea in Asthmatic Children and Teenagers
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