Sleep Apnea in Asthmatic Children and Teenagers

NCT ID: NCT03034447

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Sleep study and spirometric evaluation of children with asthma
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Asthma

Children and teenagers with persistent asthma will perform questionnaires, lung function test, and home sleep study

Group Type OTHER

Questionnaire

Intervention Type 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

Intervention Type OTHER

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

Home Sleep Study

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Lung Function Test

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

Intervention Type OTHER

Home Sleep Study

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

Intervention Type OTHER

Other Intervention Names

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Spirometry Polysomnography

Eligibility Criteria

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Inclusion Criteria

* Persistent asthma

Exclusion Criteria

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

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Gustavo Antonio Moreira

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustavo A Moreira, MD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Federal University of São Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 21809473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21465680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25539419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25375904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25461921 (View on PubMed)

Other Identifiers

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CEP/UNIFESP 1398/2016

Identifier Type: -

Identifier Source: org_study_id

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