<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/NCT03771469</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00018522</org_study_id>
    <secondary_id>GOTOL0341A</secondary_id>
    <nct_id>NCT03771469</nct_id>
  </id_info>
  <brief_title>Validation of Sleep Questionnaires in the Down Syndrome Population</brief_title>
  <official_title>Validation of Sleep Questionnaires in the Down Syndrome Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</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>
      This will be a prospective validation study of a sample of consecutive pediatric Down&#xD;
      syndrome patients who are seen through the weekly Down syndrome clinic at OHSU/Doernbecher's.&#xD;
      Questionnaires will be administered to approximately 5 new patients per month. Since this&#xD;
      population has a higher prevalence of OSA than the general pediatric population, and OSA is a&#xD;
      potentially modifiable determinant of quality of life, validated instruments are critical in&#xD;
      assessing disease burden and response to treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aims:&#xD;
&#xD;
        1. Demonstrate the criterion validity of the Sleep-Related Breathing Disorder subscale of&#xD;
           the PSQ as a screening tool for the diagnosis of OSA in children with Down Syndrome,&#xD;
           using polysomnography as the gold standard.&#xD;
&#xD;
           Hypothesis: Compared to the published threshold for a positive screen in the general&#xD;
           pediatric population (≥ 7 of 22 positive responses), the threshold for a positive screen&#xD;
           that corresponds to an optimal sensitivity and specificity in the Down syndrome&#xD;
           population will be significantly different.&#xD;
&#xD;
        2. Demonstrate the construct validity of the OSA-18 as a scale to assess sleep-related&#xD;
           quality of life in children with Down Syndrome by comparing OSA-18 scores to an&#xD;
           objective measure of disease burden (polysomnography) and a generic quality of life&#xD;
           instrument (the Pediatric Quality of Life inventory, PedsQL).&#xD;
&#xD;
      Hypothesis: OSA-18 scores will be significantly associated with the Apnea-Hypopnea Index&#xD;
      assessed by polysomnography and the PedsQL Total Score, Physical Health, and Psychosocial&#xD;
      Health summary scores.&#xD;
&#xD;
      Background:&#xD;
&#xD;
        1. Obstructive Sleep Apnea and Down Syndrome: Obstructive sleep apnea (OSA) affects 1-5% of&#xD;
           children in the US and has been associated with a myriad of health consequences&#xD;
           including cardiovascular complications, behavioral disturbances, and neurocognitive&#xD;
           dysfunction. In contrast, there is a reported OSA prevalence of 31-79% in children with&#xD;
           Down Syndrome due to traits that predispose to OSA including hypotonia, obesity, and&#xD;
           craniofacial anatomy such as midfacial and mandibular hypoplasia which can lead to&#xD;
           pharyngeal crowding. With increased risk of congenital cardiovascular defects in the&#xD;
           Down Syndrome population, it is possible that these children are also at risk of the&#xD;
           most serious complications of OSA including pulmonary hypertension.&#xD;
&#xD;
           OSA has also been shown to have a significant impact on quality of life. Behavioral&#xD;
           problems associated with OSA include reduced attention, hyperactivity, irritability and&#xD;
           problems with peers. Previous studies in the general pediatric population have shown&#xD;
           similar quality of life scores in children with symptoms of OSA as children with asthma&#xD;
           and rheumatoid arthritis. In children with Down syndrome, reduced sleep has been&#xD;
           associated with reduced cognitive function, memory, poor communication skills, and poor&#xD;
           self-help skills. Furthermore, parents of children with sleep disordered breathing often&#xD;
           suffer from sleep deprivation themselves which can result in negative impacts on family&#xD;
           life, decreased ability to care for their children and higher levels of maternal stress.&#xD;
&#xD;
        2. Subjective Measures of Sleep Disordered Breathing and Obstructive Sleep Apnea: Overnight&#xD;
           polysomnography (PSG) is the gold standard for diagnosing OSA in children. However, due&#xD;
           to cost and inconvenience, only a minority of patients being evaluated for OSA undergo&#xD;
           PSG prior to adenotonsillectomy. One survey study conducted among pediatric&#xD;
           otolaryngologists showed that 31% of respondents said they referred children suspected&#xD;
           of OSA for PSG &quot;rarely&quot; or &quot;never.&quot; In a separate study, 75% of pediatric&#xD;
           otolaryngologists surveyed referred for PSG in less than 10% of children with suspected&#xD;
           OSA. Commonly cited factors for this include cost of obtaining PSG and delay in&#xD;
           obtaining PSG due to availability. In addition, a substantial proportion of patients&#xD;
           referred for PSG are either lost to follow-up or experience significant delays in&#xD;
           treatment due to testing. As a result, alternative methods of screening for or&#xD;
           diagnosing OSA have been explored that are cheaper and less burdensome. This includes a&#xD;
           variety of questionnaires that were designed to screen the pediatric population for&#xD;
           symptoms of sleep disordered-breathing (SDB) and assess its impact on quality of life&#xD;
           within a clinic setting. The Sleep-Related Breathing Disorders subscale of the Pediatric&#xD;
           Sleep Questionnaire (SRBD-PSQ) was developed to screen for SDB using 3 categories:&#xD;
           daytime sleepiness, snoring, and behavioral disturbances.3 This has previously been&#xD;
           validated in children aged 2-18 within the general pediatric population. The OSA-18 is a&#xD;
           survey that measures the impact of SDB or OSA on disease-specific quality of life in&#xD;
           children by assessing common manifestations of the disease including sleep disturbance,&#xD;
           emotional distress, daytime function, and caregiver concerns. This questionnaire has&#xD;
           been validated in children ages 6 months to 12 years. Validated subjective measures like&#xD;
           these capture different aspects of the disease experience than objective measures like&#xD;
           PSG. They can also be used to assess large numbers of patients with far less burden and&#xD;
           expense than PSG which frequently has long wait times due to limited capacity.&#xD;
&#xD;
        3. No Validated Screening instruments or OSA-related QOL measures in Down Syndrome: Despite&#xD;
           the high prevalence of OSA in the Down syndrome population and the availability of&#xD;
           widely used questionnaires for SDB, screening for SDB is generally inconsistent in this&#xD;
           population. Even when parental report of symptoms of SDB is solicited, multiple studies&#xD;
           have demonstrated poor diagnostic accuracy of parental history compared to PSG. A recent&#xD;
           study investigating parental assessment of the symptoms of SDB found that 66% of Down&#xD;
           syndrome patients had frequent symptoms consistent with SDB including snoring, witnessed&#xD;
           apnea, and restless sleep. However, there was no association between the frequency of&#xD;
           these symptoms and diagnosis with OSA. Other studies have similarly demonstrated poor&#xD;
           diagnostic accuracy of parental history with respect to PSG findings. For this reason,&#xD;
           the most recent American Academy of Pediatrics (AAP) guideline regarding management of&#xD;
           Down syndrome patients has recommended routine screening for OSA using PSG in all&#xD;
           patients by the age of 4, regardless of symptomatology. There are currently no validated&#xD;
           instruments for screening for OSA or assessing OSA-related quality of life in the Down&#xD;
           syndrome population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 25, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</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>This will be a prospective validation study of a sample of consecutive pediatric Down syndrome patients who are seen through the weekly Down syndrome clinic at OHSU/Doernbecher's.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea-hypopnea index (AHI) from polysomnography</measure>
    <time_frame>AHI collected at initial sleep study and 3 months later (if a second sleep study is needed as determined by doctor)</time_frame>
    <description>Overnight attended polysomnography is the gold standard for diagnosis of OSA. Assessment of sleep staging is done through electroencephalogram, electro-oculogram, and submental electromyogram. The primary output parameter that is commonly used to diagnose and characterize the severity of OSA is the apnea-hypopnea index (AHI).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep Related Breathing Disorder subscale total of the Pediatric Sleep Questionnaire (SRBD-PSQ)</measure>
    <time_frame>SRBD score tallied at initial clinic visit.</time_frame>
    <description>The SRBD-PSQ is a subjective instrument with 22-items that was designed to screen for sleep-related disordered breathing in the general pediatric population. Each question is answered with a yes (1 point), no (0 points), or don't know (0 points). The total number of points is added up, and that sum is divided by the number of questions answered to produce a ratio. When assessing the ratio, a figure greater than 0.3 is considered a positive screening for OSA. There are no subscales on this questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep-Related Quality of Life (OSA-18 total score)</measure>
    <time_frame>OSA-18 total collected at initial clinic visit.</time_frame>
    <description>The OSA-18 is a subjective measure of disease-specific quality of life survey for sleep disordered breathing. It contains 18 questions. These questions are scored on a 7 point Likert scale, with &quot;1&quot; being the worst outcome and &quot;7&quot; being the best outcome. These numeric scores are totaled to produce one overall sum, with a range from 7 to 126.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generic Quality of Life</measure>
    <time_frame>PedsQL summary scores collected at initial clinic visit.</time_frame>
    <description>The Pediatric Quality of Life Inventory (PedsQL) is a validated generic quality of life measure encompassing 4 multidimensional scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning) with three Summary Scores (Total Score, Physical Health Summary Score, Psychosocial Health Summary Score). The number of questions varies by age group but falls within 20-25 questions. The questions use 5-point Likert scale from 0 (Never) to 4 (Almost always). Items are reversed scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0.). Dimensions are scored by transforming into mean score = Sum of the items over the number of items answered. For each of the 4 scales, higher scores indicate better HRQOL (better outcome).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Down Syndrome</condition>
  <arm_group>
    <arm_group_label>Questionnaires and sleep studies</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caregivers of patients meeting eligibility criteria will be invited to participate. If they agree to participate, baseline SRBD-PSQ, OSA-18, and PedsQL questionnaires along with written informed consent forms will be mailed to them along with their standard scheduling paperwork. Caregivers will be asked to review the consent form and complete the questionnaires and bring the paperwork to clinic on the day of their visit. Sleep study testing will also be ordered prior to their visit so that it can be scheduled within a month of the initial clinic visit and again three months later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sleep study</intervention_name>
    <description>Sleep study</description>
    <arm_group_label>Questionnaires and sleep studies</arm_group_label>
    <other_name>polysomnography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children with Down syndrome aged 2-17 years who are seen through the Down syndrome clinic&#xD;
        at Oregon Health and Science University who either have a recently completed sleep study&#xD;
        (within the past 6 months and no surgical treatment for OSA since then) or who will be&#xD;
        having a sleep study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of tracheostomy&#xD;
&#xD;
          -  Presence of subglottic or tracheal stenosis&#xD;
&#xD;
          -  Severe cardiopulmonary disease requiring supplemental oxygen&#xD;
&#xD;
          -  Parents or caregivers who are unable to read written English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Derek Lam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eleni O'Neill</last_name>
    <phone>503-494-3569</phone>
    <email>oneilele@ohsu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Derek Lam, MD</last_name>
    <phone>503-494-9419</phone>
    <email>lamde@ohsu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Doernbecher Children's Hospital</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eleni I O'Neill</last_name>
      <phone>503-494-3569</phone>
      <email>sabine26@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Derek Lam, MD, MPH</last_name>
      <phone>503-494-9419</phone>
      <email>lamde@ohsu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Derek Lam, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.</citation>
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  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Derek Lam, MD, MPH</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>OSA</keyword>
  <keyword>obstructive sleep apnea</keyword>
  <keyword>Down syndrome</keyword>
  <keyword>sleep questionnaires</keyword>
  <keyword>sleep study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Down Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only the PI and members of the study team will have direct access to identifiable private information. Subjects will be assigned a unique randomly generated study identification number and extracted datasets will be coded for use in subsequent analysis.</ipd_description>
  </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/NCT03771469
org study id: STUDY00018522
secondary id: GOTOL0341A
nct id: NCT03771469
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This will be a prospective validation study of a sample of consecutive pediatric Down
      syndrome patients who are seen through the weekly Down syndrome clinic at OHSU/Doernbecher's.
      Questionnaires will be administered to approximately 5 new patients per month. Since this
      population has a higher prevalence of OSA than the general pediatric population, and OSA is a
      potentially modifiable determinant of quality of life, validated instruments are critical in
      assessing disease burden and response to treatment.
Specific Aims:

        1. Demonstrate the criterion validity of the Sleep-Related Breathing Disorder subscale of
           the PSQ as a screening tool for the diagnosis of OSA in children with Down Syndrome,
           using polysomnography as the gold standard.

           Hypothesis: Compared to the published threshold for a positive screen in the general
           pediatric population (≥ 7 of 22 positive responses), the threshold for a positive screen
           that corresponds to an optimal sensitivity and specificity in the Down syndrome
           population will be significantly different.

        2. Demonstrate the construct validity of the OSA-18 as a scale to assess sleep-related
           quality of life in children with Down Syndrome by comparing OSA-18 scores to an
           objective measure of disease burden (polysomnography) and a generic quality of life
           instrument (the Pediatric Quality of Life inventory, PedsQL).

      Hypothesis: OSA-18 scores will be significantly associated with the Apnea-Hypopnea Index
      assessed by polysomnography and the PedsQL Total Score, Physical Health, and Psychosocial
      Health summary scores.

      Background:

        1. Obstructive Sleep Apnea and Down Syndrome: Obstructive sleep apnea (OSA) affects 1-5% of
           children in the US and has been associated with a myriad of health consequences
           including cardiovascular complications, behavioral disturbances, and neurocognitive
           dysfunction. In contrast, there is a reported OSA prevalence of 31-79% in children with
           Down Syndrome due to traits that predispose to OSA including hypotonia, obesity, and
           craniofacial anatomy such as midfacial and mandibular hypoplasia which can lead to
           pharyngeal crowding. With increased risk of congenital cardiovascular defects in the
           Down Syndrome population, it is possible that these children are also at risk of the
           most serious complications of OSA including pulmonary hypertension.

           OSA has also been shown to have a significant impact on quality of life. Behavioral
           problems associated with OSA include reduced attention, hyperactivity, irritability and
           problems with peers. Previous studies in the general pediatric population have shown
           similar quality of life scores in children with symptoms of OSA as children with asthma
           and rheumatoid arthritis. In children with Down syndrome, reduced sleep has been
           associated with reduced cognitive function, memory, poor communication skills, and poor
           self-help skills. Furthermore, parents of children with sleep disordered breathing often
           suffer from sleep deprivation themselves which can result in negative impacts on family
           life, decreased ability to care for their children and higher levels of maternal stress.

        2. Subjective Measures of Sleep Disordered Breathing and Obstructive Sleep Apnea: Overnight
           polysomnography (PSG) is the gold standard for diagnosing OSA in children. However, due
           to cost and inconvenience, only a minority of patients being evaluated for OSA undergo
           PSG prior to adenotonsillectomy. One survey study conducted among pediatric
           otolaryngologists showed that 31% of respondents said they referred children suspected
           of OSA for PSG "rarely" or "never." In a separate study, 75% of pediatric
           otolaryngologists surveyed referred for PSG in less than 10% of children with suspected
           OSA. Commonly cited factors for this include cost of obtaining PSG and delay in
           obtaining PSG due to availability. In addition, a substantial proportion of patients
           referred for PSG are either lost to follow-up or experience significant delays in
           treatment due to testing. As a result, alternative methods of screening for or
           diagnosing OSA have been explored that are cheaper and less burdensome. This includes a
           variety of questionnaires that were designed to screen the pediatric population for
           symptoms of sleep disordered-breathing (SDB) and assess its impact on quality of life
           within a clinic setting. The Sleep-Related Breathing Disorders subscale of the Pediatric
           Sleep Questionnaire (SRBD-PSQ) was developed to screen for SDB using 3 categories:
           daytime sleepiness, snoring, and behavioral disturbances.3 This has previously been
           validated in children aged 2-18 within the general pediatric population. The OSA-18 is a
           survey that measures the impact of SDB or OSA on disease-specific quality of life in
           children by assessing common manifestations of the disease including sleep disturbance,
           emotional distress, daytime function, and caregiver concerns. This questionnaire has
           been validated in children ages 6 months to 12 years. Validated subjective measures like
           these capture different aspects of the disease experience than objective measures like
           PSG. They can also be used to assess large numbers of patients with far less burden and
           expense than PSG which frequently has long wait times due to limited capacity.

        3. No Validated Screening instruments or OSA-related QOL measures in Down Syndrome: Despite
           the high prevalence of OSA in the Down syndrome population and the availability of
           widely used questionnaires for SDB, screening for SDB is generally inconsistent in this
           population. Even when parental report of symptoms of SDB is solicited, multiple studies
           have demonstrated poor diagnostic accuracy of parental history compared to PSG. A recent
           study investigating parental assessment of the symptoms of SDB found that 66% of Down
           syndrome patients had frequent symptoms consistent with SDB including snoring, witnessed
           apnea, and restless sleep. However, there was no association between the frequency of
           these symptoms and diagnosis with OSA. Other studies have similarly demonstrated poor
           diagnostic accuracy of parental history with respect to PSG findings. For this reason,
           the most recent American Academy of Pediatrics (AAP) guideline regarding management of
           Down syndrome patients has recommended routine screening for OSA using PSG in all
           patients by the age of 4, regardless of symptomatology. There are currently no validated
           instruments for screening for OSA or assessing OSA-related quality of life in the Down
           syndrome population.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This will be a prospective validation study of a sample of consecutive pediatric Down syndrome patients who are seen through the weekly Down syndrome clinic at OHSU/Doernbecher's.
primary purpose: Screening
masking: None (Open Label)
measure: Apnea-hypopnea index (AHI) from polysomnography
time frame: AHI collected at initial sleep study and 3 months later (if a second sleep study is needed as determined by doctor)
description: Overnight attended polysomnography is the gold standard for diagnosis of OSA. Assessment of sleep staging is done through electroencephalogram, electro-oculogram, and submental electromyogram. The primary output parameter that is commonly used to diagnose and characterize the severity of OSA is the apnea-hypopnea index (AHI).
measure: Sleep Related Breathing Disorder subscale total of the Pediatric Sleep Questionnaire (SRBD-PSQ)
time frame: SRBD score tallied at initial clinic visit.
description: The SRBD-PSQ is a subjective instrument with 22-items that was designed to screen for sleep-related disordered breathing in the general pediatric population. Each question is answered with a yes (1 point), no (0 points), or don't know (0 points). The total number of points is added up, and that sum is divided by the number of questions answered to produce a ratio. When assessing the ratio, a figure greater than 0.3 is considered a positive screening for OSA. There are no subscales on this questionnaire.
measure: Sleep-Related Quality of Life (OSA-18 total score)
time frame: OSA-18 total collected at initial clinic visit.
description: The OSA-18 is a subjective measure of disease-specific quality of life survey for sleep disordered breathing. It contains 18 questions. These questions are scored on a 7 point Likert scale, with "1" being the worst outcome and "7" being the best outcome. These numeric scores are totaled to produce one overall sum, with a range from 7 to 126.
measure: Generic Quality of Life
time frame: PedsQL summary scores collected at initial clinic visit.
description: The Pediatric Quality of Life Inventory (PedsQL) is a validated generic quality of life measure encompassing 4 multidimensional scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning) with three Summary Scores (Total Score, Physical Health Summary Score, Psychosocial Health Summary Score). The number of questions varies by age group but falls within 20-25 questions. The questions use 5-point Likert scale from 0 (Never) to 4 (Almost always). Items are reversed scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0.). Dimensions are scored by transforming into mean score = Sum of the items over the number of items answered. For each of the 4 scales, higher scores indicate better HRQOL (better outcome).
arm group label: Questionnaires and sleep studies
arm group type: Experimental
description: Caregivers of patients meeting eligibility criteria will be invited to participate. If they agree to participate, baseline SRBD-PSQ, OSA-18, and PedsQL questionnaires along with written informed consent forms will be mailed to them along with their standard scheduling paperwork. Caregivers will be asked to review the consent form and complete the questionnaires and bring the paperwork to clinic on the day of their visit. Sleep study testing will also be ordered prior to their visit so that it can be scheduled within a month of the initial clinic visit and again three months later.
intervention type: Other
intervention name: Sleep study
description: Sleep study
arm group label: Questionnaires and sleep studies
other name: polysomnography
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Derek Lam, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: Eleni O'Neill
phone: 503-494-3569
email: oneilele@ohsu.edu
last name: Derek Lam, MD
phone: 503-494-9419
email: lamde@ohsu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
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PMID: 22926173
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PMID: 1757978
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PMID: 18786953
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PMID: 16321451
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PMID: 23382017
citation: Mitchell RB, Pereira KD, Friedman NR. Sleep-disordered breathing in children: survey of current practice. Laryngoscope. 2006 Jun;116(6):956-8. doi: 10.1097/01.MLG.0000216413.22408.FD.
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PMID: 28871845
citation: Nehme J, LaBerge R, Pothos M, Barrowman N, Hoey L, Monsour A, Kukko M, Katz SL. Predicting the presence of sleep-disordered breathing in children with Down syndrome. Sleep Med. 2017 Aug;36:104-108. doi: 10.1016/j.sleep.2017.03.032. Epub 2017 May 31.
PMID: 28735906
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PMID: 1829151
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Derek Lam, MD, MPH
investigator title: Assistant Professor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Down Syndrome
mesh term: Syndrome
sharing ipd: No
ipd description: Only the PI and members of the study team will have direct access to identifiable private information. Subjects will be assigned a unique randomly generated study identification number and extracted datasets will be coded for use in subsequent analysis.