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/NCT05971212</url>
    </required_header>
    <id_info>
      <org_study_id>SCH-2530</org_study_id>
      <nct_id>NCT05971212</nct_id>
    </id_info>
    <brief_title>Sleep Support for Children With Neurodevelopmental Disorders</brief_title>
    <official_title>Can a Supportive Sleep-Practitioner-led Intervention Lead to Improved Sleep, Wellbeing and Reduced Medication Prescribing for Children With Neurodevelopmental Disorders and Co-occurring Severe Sleep Difficulties?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sheffield Children's NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sheffield Children's NHS Foundation Trust</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>
        Around 80% of children with neurodevelopmental disorders such as Attention Deficit&#xD;
        Hyperactivity Disorder (ADHD) and autism are reported to have significant difficulties with&#xD;
        sleep. This may be a problem with settling off to sleep, waking repeatedly in the night, or&#xD;
        both.&#xD;
  &#xD;
        Often these children will be prescribed a medication called melatonin to help them sleep, but&#xD;
        there is no strong evidence of its effectiveness in children, the long-term side effects are&#xD;
        not known and prescriptions for this drug cost millions of pounds a year for the NHS. Many&#xD;
        children continue to have persistent sleep problems despite taking melatonin. Sleep support&#xD;
        programmes delivered by nurses and sleep practitioners are known to be effective and to give&#xD;
        parents and young people long-term strategies for promoting sleep without the use of&#xD;
        medication. However, sleep support services are not universally funded.&#xD;
  &#xD;
        In this feasibility study 76 children with ADHD, autism or other neurodevelopmental disorder&#xD;
        who have been prescribed and have been regularly taking melatonin for at least a year but&#xD;
        still have severe sleep difficulties will be recruited. The investigators will help to&#xD;
        improve the child's sleep with a sleep practitioner support programme and, if possible,&#xD;
        reduce the dose of melatonin or stop it completely if it is no longer needed. Using this&#xD;
        design, it will be possible to test whether a programme delivered by sleep practitioners will&#xD;
        significantly improve sleep for children using a non-medical approach and in turn improve the&#xD;
        health and well-being of the child and family and reduce melatonin prescribing, thereby&#xD;
        saving NHS resources and the potential for long-term side effects. The study design will be&#xD;
        delivered by Sheffield Children's Hospital and supported by parent users, the Sleep Charity&#xD;
        and Sheffield CCG. The results will be disseminated widely to local, regional and national&#xD;
        groups as well as via social media.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sleep is a restorative process, fundamental to physical and psychological health. Sleep&#xD;
        disturbances including bedtime resistance and night-time awakening occur in 80% children with&#xD;
        neurodisability, the most common associations being with Attention Deficit Hyperactivity&#xD;
        Disorder (ADHD), Autism, cerebral palsy and syndromes such as Down, Prader-Willi and Angelman&#xD;
        syndromes. In a meta-analysis of subjective and objective studies found that ADHD is&#xD;
        associated with higher bedtime resistance, sleep-onset difficulty and longer latency, night&#xD;
        awakenings, trouble waking up in the morning, sleep-disordered breathing, daytime sleepiness,&#xD;
        more shifts between sleep stages, lower sleep efficiency and less sleep time. Anxiety and&#xD;
        depression symptoms may have a significant role in the prevalence of sleep difficulties which&#xD;
        would be clearly observed in bedtime resistance, sleep anxiety, night time awakenings and&#xD;
        sleep onset delay. Thus, teaching children how to develop sleep hygiene and the use of&#xD;
        behavioural modification to manage their fears would help children to fall asleep easily and&#xD;
        reduce bedtime resistance which therefore would improve sleep quantity and quality.&#xD;
  &#xD;
        The impact of sleep disturbance on children's health is wide-ranging with sleep deprivation&#xD;
        leading to difficulties with mood, psychosocial problems and a detrimental impact on the&#xD;
        child's cognitive ability and learning. Parents of children with sleep difficulties can&#xD;
        suffer high levels of stress and anxiety, decreased ability to work or to drive safely,&#xD;
        relationship and financial problems. These stresses lead to an increased demand on NHS&#xD;
        primary care services and to prescriptions of drugs such as antidepressants. Children with&#xD;
        significant sleep difficulties in the UK are often treated with melatonin, a hormone playing&#xD;
        a key role in the timing of sleep-wake cycle, despite the findings of a recent systematic&#xD;
        review that suggest that evidence does not strongly support its use. The drug is costly to&#xD;
        the health service, with individual Clinical Commissioning Groups (CCGs) spending up to £500k&#xD;
        per year on prescription charges for this drug alone.&#xD;
  &#xD;
        Evidence from sleep clinics delivered in the local authority, NHS and voluntary sectors has&#xD;
        shown that an intensive sleep support intervention can be highly effective. A recent&#xD;
        retrospective evaluation of a nurse-led sleep support service successfully discharged 63%&#xD;
        children without melatonin prescriptions after a median of two face-to face visits and three&#xD;
        telephone calls. The proposed study will aim to support children with neurodevelopmental&#xD;
        problems taking melatonin for sleep difficulties to develop long-term strategies for&#xD;
        promoting sleep and to reduce drug prescriptions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 29, 2021</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sleep Diary</measure>
      <time_frame>20 weeks</time_frame>
      <description>7 day sleep diary (parent report)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Actiwatch data</measure>
      <time_frame>20 weeks</time_frame>
      <description>Actiwatch worn for a 7 day period</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Child Sleep Habits Questionnaire (CSHQ)</measure>
      <time_frame>20 weeks</time_frame>
      <description>Child Sleep Habits Questionnaire (CSHQ)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Melatonin Prescription Status</measure>
      <time_frame>20 weeks</time_frame>
      <description>Questionnaire (designed by researchers) asking about patient dosage and type of melatonin taken</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Strengths and Difficulties Questionnaire (SDQ)</measure>
      <time_frame>20 weeks</time_frame>
      <description>Strengths and Difficulties Questionnaire (SDQ)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CHU-9D Quality of Life questionnaire</measure>
      <time_frame>20 weeks</time_frame>
      <description>CHU-9D Quality of Life questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare Utilisation</measure>
      <time_frame>20 weeks</time_frame>
      <description>Questionnaire (designed by researchers) recording how many times patient has accessed healthcare settings/professionals in last year</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parent Wellbeing</measure>
      <time_frame>20 weeks</time_frame>
      <description>Warwick- Edinburgh Mental Wellbeing Scale</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Sleep Hygiene</condition>
    <condition>Sleep Wake Disorders</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Access to Sleep Clinic immediately</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Access to Sleep Clinic delayed</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioural sleep clinic access</intervention_name>
      <description>Access to behavioural Sleep Clinic</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children to be included will fulfil all of the inclusion criteria.&#xD;
  &#xD;
                 -  Formal diagnosis of ADHD, autism or another neurodevelopmental condition,&#xD;
  &#xD;
                 -  Age 4-11 years,&#xD;
  &#xD;
                 -  Severe sleep disturbance (defined as Score of 3 or more on Composite Sleep&#xD;
                    Disturbance Index),&#xD;
  &#xD;
                 -  Been taking melatonin to aid sleep onset for more than 12 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion Criteria&#xD;
  &#xD;
                 -  Already accessed a sleep clinic at Sheffield Children's Hospital or The Sleep&#xD;
                    Charity.&#xD;
  &#xD;
                 -  English not first language&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>11 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Heather Elphick</last_name>
      <role>Study Director</role>
      <affiliation>Sheffield Children's NHS Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Heather Elphick</last_name>
      <phone>01142 717000</phone>
      <email>h.elphick@nhs.net</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinical Research Facility, Sheffield Children's Hospital</name>
        <address>
          <city>Sheffield</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Heather Elphick</last_name>
        <phone>0114 2717000</phone>
        <email>h.elphick@nhs.net</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Wake Disorders</mesh_term>
      <mesh_term>Neurodevelopmental Disorders</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/NCT05971212
  org study id: SCH-2530
  nct id: NCT05971212
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Around 80% of children with neurodevelopmental disorders such as Attention Deficit
        Hyperactivity Disorder (ADHD) and autism are reported to have significant difficulties with
        sleep. This may be a problem with settling off to sleep, waking repeatedly in the night, or
        both.
  
        Often these children will be prescribed a medication called melatonin to help them sleep, but
        there is no strong evidence of its effectiveness in children, the long-term side effects are
        not known and prescriptions for this drug cost millions of pounds a year for the NHS. Many
        children continue to have persistent sleep problems despite taking melatonin. Sleep support
        programmes delivered by nurses and sleep practitioners are known to be effective and to give
        parents and young people long-term strategies for promoting sleep without the use of
        medication. However, sleep support services are not universally funded.
  
        In this feasibility study 76 children with ADHD, autism or other neurodevelopmental disorder
        who have been prescribed and have been regularly taking melatonin for at least a year but
        still have severe sleep difficulties will be recruited. The investigators will help to
        improve the child's sleep with a sleep practitioner support programme and, if possible,
        reduce the dose of melatonin or stop it completely if it is no longer needed. Using this
        design, it will be possible to test whether a programme delivered by sleep practitioners will
        significantly improve sleep for children using a non-medical approach and in turn improve the
        health and well-being of the child and family and reduce melatonin prescribing, thereby
        saving NHS resources and the potential for long-term side effects. The study design will be
        delivered by Sheffield Children's Hospital and supported by parent users, the Sleep Charity
        and Sheffield CCG. The results will be disseminated widely to local, regional and national
        groups as well as via social media.
  Sleep is a restorative process, fundamental to physical and psychological health. Sleep
        disturbances including bedtime resistance and night-time awakening occur in 80% children with
        neurodisability, the most common associations being with Attention Deficit Hyperactivity
        Disorder (ADHD), Autism, cerebral palsy and syndromes such as Down, Prader-Willi and Angelman
        syndromes. In a meta-analysis of subjective and objective studies found that ADHD is
        associated with higher bedtime resistance, sleep-onset difficulty and longer latency, night
        awakenings, trouble waking up in the morning, sleep-disordered breathing, daytime sleepiness,
        more shifts between sleep stages, lower sleep efficiency and less sleep time. Anxiety and
        depression symptoms may have a significant role in the prevalence of sleep difficulties which
        would be clearly observed in bedtime resistance, sleep anxiety, night time awakenings and
        sleep onset delay. Thus, teaching children how to develop sleep hygiene and the use of
        behavioural modification to manage their fears would help children to fall asleep easily and
        reduce bedtime resistance which therefore would improve sleep quantity and quality.
  
        The impact of sleep disturbance on children's health is wide-ranging with sleep deprivation
        leading to difficulties with mood, psychosocial problems and a detrimental impact on the
        child's cognitive ability and learning. Parents of children with sleep difficulties can
        suffer high levels of stress and anxiety, decreased ability to work or to drive safely,
        relationship and financial problems. These stresses lead to an increased demand on NHS
        primary care services and to prescriptions of drugs such as antidepressants. Children with
        significant sleep difficulties in the UK are often treated with melatonin, a hormone playing
        a key role in the timing of sleep-wake cycle, despite the findings of a recent systematic
        review that suggest that evidence does not strongly support its use. The drug is costly to
        the health service, with individual Clinical Commissioning Groups (CCGs) spending up to £500k
        per year on prescription charges for this drug alone.
  
        Evidence from sleep clinics delivered in the local authority, NHS and voluntary sectors has
        shown that an intensive sleep support intervention can be highly effective. A recent
        retrospective evaluation of a nurse-led sleep support service successfully discharged 63%
        children without melatonin prescriptions after a median of two face-to face visits and three
        telephone calls. The proposed study will aim to support children with neurodevelopmental
        problems taking melatonin for sleep difficulties to develop long-term strategies for
        promoting sleep and to reduce drug prescriptions.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Single (Care Provider)
  measure: Sleep Diary
  time frame: 20 weeks
  description: 7 day sleep diary (parent report)
  measure: Actiwatch data
  time frame: 20 weeks
  description: Actiwatch worn for a 7 day period
  measure: Child Sleep Habits Questionnaire (CSHQ)
  time frame: 20 weeks
  description: Child Sleep Habits Questionnaire (CSHQ)
  measure: Melatonin Prescription Status
  time frame: 20 weeks
  description: Questionnaire (designed by researchers) asking about patient dosage and type of melatonin taken
  measure: Strengths and Difficulties Questionnaire (SDQ)
  time frame: 20 weeks
  description: Strengths and Difficulties Questionnaire (SDQ)
  measure: CHU-9D Quality of Life questionnaire
  time frame: 20 weeks
  description: CHU-9D Quality of Life questionnaire
  measure: Healthcare Utilisation
  time frame: 20 weeks
  description: Questionnaire (designed by researchers) recording how many times patient has accessed healthcare settings/professionals in last year
  measure: Parent Wellbeing
  time frame: 20 weeks
  description: Warwick- Edinburgh Mental Wellbeing Scale
  arm group label: Intervention
  arm group type: Experimental
  description: Access to Sleep Clinic immediately
  arm group label: Control
  arm group type: Experimental
  description: Access to Sleep Clinic delayed
  intervention type: Behavioral
  intervention name: Behavioural sleep clinic access
  description: Access to behavioural Sleep Clinic
  arm group label: Control
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 11 Years
  healthy volunteers: No
  last name: Heather Elphick
  role: Study Director
  affiliation: Sheffield Children's NHS Trust
  last name: Heather Elphick
  phone: 01142 717000
  email: h.elphick@nhs.net
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Sleep Wake Disorders
  mesh term: Neurodevelopmental Disorders
  sharing ipd: No