Sleep Apnea in Asthmatic Children and Teenagers

NCT03034447 | Completed

• 1 other identifier: CEP/UNIFESP 1398/2016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Sleep Apnea Syndrome

  Apneas and hypopneas during sleep

  1 night

Secondary Outcomes (3)

• Asthma Control

  4 weeks

• ER visits

  1 year

• Lung function

  1 day

Study Arms (1)

Asthma

OTHER

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

Other: Questionnaire; Other: Lung Function Test; Other: Home Sleep Study

Interventions

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

Asthma

Lung Function Test OTHER

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

Also known as: Spirometry

Asthma

Home Sleep Study OTHER

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

Also known as: Polysomnography

Asthma

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Persistent asthma

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Associação Fundo de Incentivo à Pesquisa: collaborator

Study Sites (1)

Federal University of São Paulo

São Paulo, 04021-001, Brazil

Location

Related Publications (5)

• 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.

  PMID: 21809473 BACKGROUND

• 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.

  PMID: 21465680 BACKGROUND

• 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.

  PMID: 25539419 BACKGROUND

• 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.

  PMID: 25375904 BACKGROUND

• 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.

  PMID: 25461921 BACKGROUND

MeSH Terms

Conditions

Asthma; Sleep Apnea Syndromes; Disease; Sleep Apnea, Obstructive

Interventions

Surveys and Questionnaires; Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Gustavo A Moreira, MD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Sleep study and spirometric evaluation of children with asthma

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 27, 2017
• Study Start: December 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

BR (1)