<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03034447</url>
  </required_header>
  <id_info>
    <org_study_id>CEP/UNIFESP 1398/2016</org_study_id>
    <nct_id>NCT03034447</nct_id>
  </id_info>
  <brief_title>Sleep Apnea in Asthmatic Children and Teenagers</brief_title>
  <official_title>Obstructive Sleep Apnea in Asthmatic Children: Does the Sex Matter?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Associação Fundo de Incentivo à Pesquisa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Asthma and sleep apnea are both respiratory diseases and one can worsen the other. Those who&#xD;
      suffer from asthma have a higher risk of sleep apnea and sleep apnea can make the asthma more&#xD;
      difficult to control.&#xD;
&#xD;
      As girls usually have a more severe asthma than boys, the investigators believe that girls&#xD;
      have a higher risk of sleep apnea.&#xD;
&#xD;
      To test if asthmatic girls have more sleep apnea than boys, the investigators are going to&#xD;
      ask them questions regarding asthma and sleep symptoms (such as snore) and the investigators&#xD;
      are going test the lung function and how many times they stop breathing during the sleep. The&#xD;
      sleep test is going to be performed in children's home.&#xD;
&#xD;
      In children, having sleep apnea can make the asthmatic stay in the hospital 30% more when&#xD;
      they have an asthma attack. We also are going to look if sleep apnea increases the number of&#xD;
      hospitalizations and asthma attacks in the past 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea (OSA) and asthma are both inflammatory airway diseases. A systematic&#xD;
      review regarding sleep-disordered breathing (SDB) in asthmatic children analyzed 17 studies&#xD;
      but only two of them had objective OSA measurement. In total, 45,115 children were included,&#xD;
      53% boys, mean age 8.6 ± 2.5 years. SDB was present in 23.8% of asthmatic children and in&#xD;
      16.7% of non-asthmatic (p &lt; 0.001, OR 1.9, 95%CI 1.7-2.2).&#xD;
&#xD;
      An American study found that OSA in asthmatic children increases hospital length of stay (OR&#xD;
      2.3; 95% CI = 1.8 - 2.9). Brazilian database of the year 2015 showed that, among children&#xD;
      5-19 years, asthma was the 5th cause of hospitalization: a total of 2.4% of the&#xD;
      hospitalization in this age group, after birth and its complication (31%), limb fractures&#xD;
      (5.7%), pneumonia (3.8%), and appendicitis (3.2%).&#xD;
&#xD;
      The relationship among asthma severity (mild, moderate, and severe) and OSA has been&#xD;
      described previously, but not in every study. Poor asthma control has also been linked to a&#xD;
      higher OSA risk in adults and children.&#xD;
&#xD;
      OSA and asthma share many risk factors: rhinitis, increased collapsibility of the upper&#xD;
      airway, local and systemic inflammation, gastroesophageal reflux, and obesity.&#xD;
&#xD;
      A higher risk of SDB in asthmatic girls has recently been described (OR 2.55 for girls and&#xD;
      0.70 for boys). Among non-asthmatic children OSA is usually equal among boys and girls until&#xD;
      adolescence. A possible explanation is asthma severity in children: younger boys are more&#xD;
      severe but after puberty, girls are.&#xD;
&#xD;
      Since OSA and asthma are linked diseases and that little is known about them in the pediatric&#xD;
      field, specially differences related to sex, the investigators hypothesize that: 1) asthmatic&#xD;
      girls have a higher OSA risk; 2) OSA will be higher in asthmatic children compared to the&#xD;
      pediatric literature; 3) asthma severity, asthma control, and rhinitis will be related to a&#xD;
      higher OSA risk. The investigators also aim to analyze factors associated with a higher risk&#xD;
      of hospitalizations and asthma attacks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Sleep study and spirometric evaluation of children with asthma</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Apnea Syndrome</measure>
    <time_frame>1 night</time_frame>
    <description>Apneas and hypopneas during sleep</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma Control</measure>
    <time_frame>4 weeks</time_frame>
    <description>Asthma Control based on Global Initiative for Asthma (GINA) questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ER visits</measure>
    <time_frame>1 year</time_frame>
    <description>How many times went to hospital the previous year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function</measure>
    <time_frame>1 day</time_frame>
    <description>Currently lung function</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Asthma, Bronchial</condition>
  <condition>Bronchial Asthma</condition>
  <condition>Apnea, Sleep</condition>
  <condition>Sleep Apnea, Mixed Central and Obstructive</condition>
  <condition>Sleep Hypopnea (Diagnosis)</condition>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Asthma</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Children and teenagers with persistent asthma will perform questionnaires, lung function test, and home sleep study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <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</description>
    <arm_group_label>Asthma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lung Function Test</intervention_name>
    <description>Children are going to blow in a machine that measures how the lung is working</description>
    <arm_group_label>Asthma</arm_group_label>
    <other_name>Spirometry</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Sleep Study</intervention_name>
    <description>Children are going to sleep at home with a device that tells if they stop breathing during sleep</description>
    <arm_group_label>Asthma</arm_group_label>
    <other_name>Polysomnography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persistent asthma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Craniofacial malformation&#xD;
&#xD;
          -  Thoracic malformation&#xD;
&#xD;
          -  Genetic syndromes&#xD;
&#xD;
          -  Bronchopulmonary dysplasia&#xD;
&#xD;
          -  Bronchiolitis obliterans&#xD;
&#xD;
          -  Neuromuscular diseases&#xD;
&#xD;
          -  Sickle cell anemia&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gustavo A Moreira, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>04021-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>21809473</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21465680</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25539419</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25375904</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25461921</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Gustavo Antonio Moreira</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Obstructive Sleep Apnea</keyword>
  <keyword>Children</keyword>
  <keyword>Teenagers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03034447
org study id: CEP/UNIFESP 1398/2016
nct id: NCT03034447
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Sleep study and spirometric evaluation of children with asthma
primary purpose: Health Services Research
masking: None (Open Label)
measure: Sleep Apnea Syndrome
time frame: 1 night
description: Apneas and hypopneas during sleep
measure: Asthma Control
time frame: 4 weeks
description: Asthma Control based on Global Initiative for Asthma (GINA) questions
measure: ER visits
time frame: 1 year
description: How many times went to hospital the previous year
measure: Lung function
time frame: 1 day
description: Currently lung function
arm group label: Asthma
arm group type: Other
description: Children and teenagers with persistent asthma will perform questionnaires, lung function test, and home sleep study
intervention type: Other
intervention name: Questionnaire
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
arm group label: Asthma
intervention type: Other
intervention name: Lung Function Test
description: Children are going to blow in a machine that measures how the lung is working
arm group label: Asthma
other name: Spirometry
intervention type: Other
intervention name: Home Sleep Study
description: Children are going to sleep at home with a device that tells if they stop breathing during sleep
arm group label: Asthma
other name: Polysomnography
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Gustavo A Moreira, MD
role: Study Chair
affiliation: Federal University of São Paulo
facility: 
country: Brazil
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.
PMID: 21809473
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.
PMID: 21465680
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.
PMID: 25539419
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.
PMID: 25375904
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.
PMID: 25461921
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Gustavo Antonio Moreira
investigator title: Medical Doctor
mesh term: Asthma
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided