xml: <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/NCT06030349</url>
    </required_header>
    <id_info>
      <org_study_id>REC137-22</org_study_id>
      <nct_id>NCT06030349</nct_id>
    </id_info>
    <brief_title>Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome</brief_title>
    <acronym>REFRESHED</acronym>
    <official_title>Real World Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea Syndrome in Children With Down Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Health Ireland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Southampton Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Royal Hospital for Children &amp; Young People, Edinburgh</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Birmingham Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Royal Belfast Hospital for Sick Children</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Children's Health Ireland</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>
        The goal of this observational study is to learn about the use of non-invasive ventilation&#xD;
        for treatment of obstructive sleep apnoea syndrome in children with Down Syndrome. The main&#xD;
        questions it aims to answer are:&#xD;
  &#xD;
          -  What is the impact of non-invasive ventilation on sleep behaviours and quality of life?&#xD;
  &#xD;
          -  What barriers are faced by children and their families in establishing tolerance to&#xD;
             non-invasive ventilation?&#xD;
  &#xD;
        Participants will be asked to complete questionnaires before and after starting treatment.&#xD;
        Researchers will compare this data with the results of sleep studies and non-invasive&#xD;
        ventilator downloads recorded as part of standard medical care. A sub-group of up to 20&#xD;
        participants will be invited to take part in 45-60 minute interviews exploring expectations,&#xD;
        experiences and barriers encountered during non-invasive ventilation therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Our aim is to examine the impact of non-invasive ventilation for treatment of obstructive&#xD;
        sleep apnoea syndrome in children with Down Syndrome on behavioural and quality of life&#xD;
        outcomes and to establish the specific barriers experienced in establishing adherence to&#xD;
        treatment.&#xD;
  &#xD;
        Information from clinical assessment, sleep studies and device downloads recorded as part of&#xD;
        standard care will be combined with questionnaire data to assess for changes in behaviour and&#xD;
        quality of life. All participants will undergo questionnaire assessment of barriers&#xD;
        experienced. A sub-group of up to 20 participants will be invited to take part in 45-60&#xD;
        minute semi-structured interviews exploring expectations, experiences and barriers&#xD;
        encountered.&#xD;
  &#xD;
        This study will take place in 5 sites across Ireland and the United Kingdom over a 5-year&#xD;
        study period. The study has its base in Children's Health Ireland where the principal&#xD;
        investigator and project manager are based and co-ordinate all aspects of study conduct and&#xD;
        management. Statistical, data management and bioinformatics aspects of the study will be&#xD;
        coordinated through the Research and Innovation Office at Children's Health Ireland.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 28, 2022</start_date>
    <completion_date type="Anticipated">December 28, 2027</completion_date>
    <primary_completion_date type="Anticipated">November 28, 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome &gt; 3 years.</measure>
      <time_frame>Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment</time_frame>
      <description>Change in Obstructive Sleep Apnoea - 18 scores (Range 0- 126, Higher scores indicating worse quality of life) from baseline will be used to evaluate for improvement in sleep related breathing specific quality of life in children &gt;3 years. Sleep disturbance, physical suffering, emotional distress, daytime problems and caregiver concern subscales will also be evaluated for change.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome &lt; 3 years.</measure>
      <time_frame>Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment</time_frame>
      <description>Change in Infant Toddler Quality of Life - Short Form 47 scores (Range 0 - 100, Higher scores indicating greater quality of life) from baseline will be used to evaluate for improvement in sleep related breathing specific quality of life in children &lt; 3 years. Infant and parent subscales will also be evaluated for change.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on caregiver concerns regarding sleep disordered breathing for caregivers of children with Down Syndrome &lt; 3 years.</measure>
      <time_frame>Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment</time_frame>
      <description>Change in Caregiver-concern domain of the Obstructive Sleep Apnoea - 18 (Range 0 - 28, Higher scores indicating worse quality of life) from baseline will be used to evaluate for change in caregiver concern regarding sleep disordered breathing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome &gt; 3 years.</measure>
      <time_frame>Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment</time_frame>
      <description>Change in Child Sleep Habits Questionnaire scores (Range 0 - 97, Higher scores indicating greater sleeping difficulties) from baseline will be used to evaluate for overall improvement in sleep behaviours in children &gt; 3 years. Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnia, sleep disordered breathing and daytime sleepiness subscales will also be evaluated for change.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome &lt; 3 years.</measure>
      <time_frame>Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment</time_frame>
      <description>Change in Brief Infant Sleep Questionnaire scores (Range 0 - 100, Lower scores indicating greater sleeping difficulties) from baseline will be used to evaluate for overall improvement in sleep behaviours in children &lt; 3 years. Infant sleep, parent perception and parent behaviour subscales will also be evaluated for change.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To establish the specific barriers to adherence faced by children &gt; 3 years with Down Syndrome and their caregivers when starting non-invasive ventilation for the treatment of obstructive sleep apnoea syndrome</measure>
      <time_frame>Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment</time_frame>
      <description>Quantitative assessment of barriers encountered in establishing adherence will be evaluated using the Continuous Positive Airway Pressure Questionnaire (Range 29-145, Higher scores indicating greater barriers to adherence) for children &gt; 3 years. Behaviours/belief/environment, emotional and physical subscales will also be evaluated for change.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To establish the specific barriers to adherence faced by children &lt; 3 years with Down Syndrome and their caregivers when starting non-invasive ventilation for the treatment of obstructive sleep apnoea syndrome</measure>
      <time_frame>Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment</time_frame>
      <description>Quantitative assessment of barriers encountered in establishing adherence will be evaluated using the Modified Continuous Positive Airway Pressure Questionnaire (Range 27 - 135, Higher scores indicating greater barriers to adherence) for children &lt; 3 years. This is a non-validated questionnaire developed by our research group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of expectations, experiences and barriers experienced by families in the treatment of obstructive sleep apnoea syndrome with non-invasive ventilation</measure>
      <time_frame>After 8 weeks of attempted initiation of non-invasive ventilation</time_frame>
      <description>Qualitative assessment of expectations, experiences and barriers experienced during non-invasive ventilation treatment will be explored through semi-structured interviews to add nuance to the outcomes around efficacy of treatment, quality of life, behaviour, and treatment adherence</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Obstructive Sleep Apnea</condition>
    <condition>Down Syndrome</condition>
    <condition>Quality of Life</condition>
    <condition>Behavior</condition>
    <condition>Adherence, Treatment</condition>
    <arm_group>
      <arm_group_label>Standard</arm_group_label>
      <description>In addition to data from clinical assessment, sleep studies and non-invasive ventilator downloads recorded as part of standard care participants will undergo questionnaire assessment of behaviour, quality of life and barriers to tolerating treatment. Participants aged 3 years and above will receive the Child Sleep Habits Questionnaire, Obstructive Sleep Apnoea-18 questionnaire and Adherence Barriers to CPAP (Continuous Positive Airway Pressure) Questionnaire. Participants aged 6 months to 3 years will receive the Brief Infant Sleep Questionnaire, Infant Toddler Quality of Life - Short Form 47, Obstructive Sleep Apnoea -18 Caregiver Concern Domain and a modified version of the Adherence Barriers to CPAP Questionnaire.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Advanced</arm_group_label>
      <description>In addition to all elements of the standard testing group, a sub-group of up to 20 participants will be invited to take part in 45-60 minute semi-structured interviews exploring expectations, experiences and barriers encountered.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Non-invasive ventilation</intervention_name>
      <description>Non-invasive ventilation</description>
      <arm_group_label>Advanced</arm_group_label>
      <arm_group_label>Standard</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children with Down Syndrome referred for evaluation for suspected sleep disordered&#xD;
          breathing&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals with a confirmed diagnosis of Down Syndrome where a clinical decision has&#xD;
               been made to initiate respiratory support with non-invasive ventilation.&#xD;
  &#xD;
            -  Obstructive Apnoea Hypopnoea Index &gt; 2 episodes/hour or where sleep disordered&#xD;
               breathing symptoms occur in combination with an Apnoea Hypopnoea Index &gt; 1 episode/hr.&#xD;
               - English language proficiency.&#xD;
  &#xD;
            -  Age ≥ 6 months at the commencement of therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals not willing to comply with study procedures or assessments.&#xD;
  &#xD;
            -  Individuals for whom ventilatory support devices are already prescribed and those with&#xD;
               artificial airways.&#xD;
  &#xD;
            -  Individuals on clinical trials of investigational support therapies.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sheila Javadpour</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's Health Ireland</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Roy G Stone</last_name>
      <phone>0035314282626</phone>
      <phone_ext>604</phone_ext>
      <email>refreshed@olchc.ie</email>
    </overall_contact>
    <location>
      <facility>
        <name>Trinity College Dublin</name>
        <address>
          <city>Dublin</city>
          <zip>D02 PN40</zip>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ruth Monaghan</last_name>
      </contact>
      <investigator>
        <last_name>Elizabeth Nixon</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ruth Monaghan</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Children's Health Ireland</name>
        <address>
          <city>Dublin</city>
          <zip>D12 N512</zip>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Roy G Stone</last_name>
        <phone>0035314282626</phone>
        <phone_ext>604</phone_ext>
        <email>refreshed@olchc.ie</email>
      </contact>
      <investigator>
        <last_name>Sheila Javadpour</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Roy G Stone</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lisa Farrell</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Anne-Marie Casey</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Royal Belfast Hospital for Sick Children</name>
        <address>
          <city>Belfast</city>
          <zip>BT12 6BA</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Dara O'Donoghue</last_name>
      </contact>
      <investigator>
        <last_name>Dara O'Donoghue</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Barbara Maxwell</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ruth Harte</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Birmingham Children's Hospital</name>
        <address>
          <city>Birmingham</city>
          <zip>B4 6NH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Priti Kenia</last_name>
      </contact>
      <investigator>
        <last_name>Priti Kenia</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Royal Hospital for Children &amp; Young People</name>
        <address>
          <city>Edinburgh</city>
          <zip>EH16 4TJ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Florian Gahleitner</last_name>
      </contact>
      <investigator>
        <last_name>Florian Gahleitner</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Southampton Children's Hospital</name>
        <address>
          <city>Southampton</city>
          <zip>SO16 6YD</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Hazel Evans</last_name>
      </contact>
      <contact_backup>
        <last_name>Catherine M Hill</last_name>
      </contact_backup>
      <investigator>
        <last_name>Hazel Evans</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Catherine M Hill</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Ireland</country>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Health Ireland</investigator_affiliation>
      <investigator_full_name>Sheila Javadpour</investigator_full_name>
      <investigator_title>Clinical Lead for Respiratory Sleep Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Apnea</mesh_term>
      <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>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030349
  org study id: REC137-22
  nct id: NCT06030349
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the use of non-invasive ventilation
        for treatment of obstructive sleep apnoea syndrome in children with Down Syndrome. The main
        questions it aims to answer are:
  
          -  What is the impact of non-invasive ventilation on sleep behaviours and quality of life?
  
          -  What barriers are faced by children and their families in establishing tolerance to
             non-invasive ventilation?
  
        Participants will be asked to complete questionnaires before and after starting treatment.
        Researchers will compare this data with the results of sleep studies and non-invasive
        ventilator downloads recorded as part of standard medical care. A sub-group of up to 20
        participants will be invited to take part in 45-60 minute interviews exploring expectations,
        experiences and barriers encountered during non-invasive ventilation therapy.
  Our aim is to examine the impact of non-invasive ventilation for treatment of obstructive
        sleep apnoea syndrome in children with Down Syndrome on behavioural and quality of life
        outcomes and to establish the specific barriers experienced in establishing adherence to
        treatment.
  
        Information from clinical assessment, sleep studies and device downloads recorded as part of
        standard care will be combined with questionnaire data to assess for changes in behaviour and
        quality of life. All participants will undergo questionnaire assessment of barriers
        experienced. A sub-group of up to 20 participants will be invited to take part in 45-60
        minute semi-structured interviews exploring expectations, experiences and barriers
        encountered.
  
        This study will take place in 5 sites across Ireland and the United Kingdom over a 5-year
        study period. The study has its base in Children's Health Ireland where the principal
        investigator and project manager are based and co-ordinate all aspects of study conduct and
        management. Statistical, data management and bioinformatics aspects of the study will be
        coordinated through the Research and Innovation Office at Children's Health Ireland.
  observational model: Cohort
  time perspective: Prospective
  measure: To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome > 3 years.
  time frame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
  description: Change in Obstructive Sleep Apnoea - 18 scores (Range 0- 126, Higher scores indicating worse quality of life) from baseline will be used to evaluate for improvement in sleep related breathing specific quality of life in children >3 years. Sleep disturbance, physical suffering, emotional distress, daytime problems and caregiver concern subscales will also be evaluated for change.
  measure: To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome < 3 years.
  time frame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
  description: Change in Infant Toddler Quality of Life - Short Form 47 scores (Range 0 - 100, Higher scores indicating greater quality of life) from baseline will be used to evaluate for improvement in sleep related breathing specific quality of life in children < 3 years. Infant and parent subscales will also be evaluated for change.
  measure: To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on caregiver concerns regarding sleep disordered breathing for caregivers of children with Down Syndrome < 3 years.
  time frame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
  description: Change in Caregiver-concern domain of the Obstructive Sleep Apnoea - 18 (Range 0 - 28, Higher scores indicating worse quality of life) from baseline will be used to evaluate for change in caregiver concern regarding sleep disordered breathing.
  measure: To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome > 3 years.
  time frame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
  description: Change in Child Sleep Habits Questionnaire scores (Range 0 - 97, Higher scores indicating greater sleeping difficulties) from baseline will be used to evaluate for overall improvement in sleep behaviours in children > 3 years. Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnia, sleep disordered breathing and daytime sleepiness subscales will also be evaluated for change.
  measure: To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome < 3 years.
  time frame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
  description: Change in Brief Infant Sleep Questionnaire scores (Range 0 - 100, Lower scores indicating greater sleeping difficulties) from baseline will be used to evaluate for overall improvement in sleep behaviours in children < 3 years. Infant sleep, parent perception and parent behaviour subscales will also be evaluated for change.
  measure: To establish the specific barriers to adherence faced by children > 3 years with Down Syndrome and their caregivers when starting non-invasive ventilation for the treatment of obstructive sleep apnoea syndrome
  time frame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
  description: Quantitative assessment of barriers encountered in establishing adherence will be evaluated using the Continuous Positive Airway Pressure Questionnaire (Range 29-145, Higher scores indicating greater barriers to adherence) for children > 3 years. Behaviours/belief/environment, emotional and physical subscales will also be evaluated for change.
  measure: To establish the specific barriers to adherence faced by children < 3 years with Down Syndrome and their caregivers when starting non-invasive ventilation for the treatment of obstructive sleep apnoea syndrome
  time frame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
  description: Quantitative assessment of barriers encountered in establishing adherence will be evaluated using the Modified Continuous Positive Airway Pressure Questionnaire (Range 27 - 135, Higher scores indicating greater barriers to adherence) for children < 3 years. This is a non-validated questionnaire developed by our research group.
  measure: Assessment of expectations, experiences and barriers experienced by families in the treatment of obstructive sleep apnoea syndrome with non-invasive ventilation
  time frame: After 8 weeks of attempted initiation of non-invasive ventilation
  description: Qualitative assessment of expectations, experiences and barriers experienced during non-invasive ventilation treatment will be explored through semi-structured interviews to add nuance to the outcomes around efficacy of treatment, quality of life, behaviour, and treatment adherence
  arm group label: Standard
  description: In addition to data from clinical assessment, sleep studies and non-invasive ventilator downloads recorded as part of standard care participants will undergo questionnaire assessment of behaviour, quality of life and barriers to tolerating treatment. Participants aged 3 years and above will receive the Child Sleep Habits Questionnaire, Obstructive Sleep Apnoea-18 questionnaire and Adherence Barriers to CPAP (Continuous Positive Airway Pressure) Questionnaire. Participants aged 6 months to 3 years will receive the Brief Infant Sleep Questionnaire, Infant Toddler Quality of Life - Short Form 47, Obstructive Sleep Apnoea -18 Caregiver Concern Domain and a modified version of the Adherence Barriers to CPAP Questionnaire.
  arm group label: Advanced
  description: In addition to all elements of the standard testing group, a sub-group of up to 20 participants will be invited to take part in 45-60 minute semi-structured interviews exploring expectations, experiences and barriers encountered.
  intervention type: Device
  intervention name: Non-invasive ventilation
  description: Non-invasive ventilation
  arm group label: Advanced
  arm group label: Standard
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 16 Years
  healthy volunteers: No
  last name: Sheila Javadpour
  role: Principal Investigator
  affiliation: Children's Health Ireland
  last name: Roy G Stone
  phone: 0035314282626
  phone ext: 604
  email: refreshed@olchc.ie
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Ireland
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: Children's Health Ireland
  investigator full name: Sheila Javadpour
  investigator title: Clinical Lead for Respiratory Sleep Medicine
  mesh term: Apnea
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Down Syndrome
  mesh term: Syndrome
  sharing ipd: No