<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/NCT04416789</url>
  </required_header>
  <id_info>
    <org_study_id>237572</org_study_id>
    <nct_id>NCT04416789</nct_id>
  </id_info>
  <brief_title>Exercise Intervention for Sleep in Neurodevelopmental Disorders</brief_title>
  <official_title>A Feasibility Study to Determine the Acceptability and Impact of an Exercise Intervention for Children With Neurodevelopmental Difficulties and Sleep Problems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guy's and St Thomas' 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>
      There is a long-standing assumption that physical activity is an effective,&#xD;
      non-pharmacological approach to improving sleep quality and quantity. However, objective and&#xD;
      reliable data on this relationship are scarce for children with developmental disabilities.&#xD;
&#xD;
      Parent burnout in this population is high and there are many barriers to engagement with such&#xD;
      interventions. This study aims to understand the feasibility of providing an exercise&#xD;
      intervention for this population, and gathering parental views on the impact of such an&#xD;
      intervention.&#xD;
&#xD;
      Depending on the outcome of this feasibilty study, larger scale interventions may be planned&#xD;
      to further examine the impact of such an intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exercise in this population:&#xD;
&#xD;
      The impact of exercise on sleep in children with developmental disabilities is so far&#xD;
      tentative. Small-scale studies suggest increasing physical activity in children with&#xD;
      neurodevelopmental disorders leads to increased sleep quality.&#xD;
&#xD;
      Recommendations from previous research have included that future studies should assess the&#xD;
      benefit of a longer intervention period, and impact on the wider family. Our study design&#xD;
      aims to address these two factors.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Feasibility study using a one sample pre-post design.&#xD;
&#xD;
      Recruitment:&#xD;
&#xD;
      Participants will be informed of the study during the standard clinic assessment run by the&#xD;
      Community Paediatricians (Community Sleep Clinic Lambeth and Southwark). A &quot;consent to be&#xD;
      contacted&quot; letter will be used to facilitate agreement for the research team to contact&#xD;
      families to discuss the study in more detail. Families will then be contacted by a member of&#xD;
      the team not directly linked to their care. Information will be given over the phone and the&#xD;
      family invited to a study information session at which the study will be explained further,&#xD;
      questions answered, and consent taken for those who wish to take part.&#xD;
&#xD;
      During and after completion of the intervention all participants will continue through the&#xD;
      usual treatment pathway.&#xD;
&#xD;
      Figure one: participant flow diagram:&#xD;
&#xD;
      Baseline assessment - parent to complete 2 weeks of sleep diaries for child prior to&#xD;
      intervention; child height and weight measurement.&#xD;
&#xD;
      Intervention - 1 session of swimming (1.5 hours) and 1 session of trampolining and dry sports&#xD;
      (1.5 hours) per week for 10 weeks, totalling 20 x 1.5 hours. The intervention will be&#xD;
      tailored to the level of ability for each participant (i.e. each exercise will have different&#xD;
      levels of complexity). Details of the specifics of the intervention that will be undertaken&#xD;
      by the participants is as above. The intervention will be provided by the 'London PE and&#xD;
      Schools Sport Network'. This company is a well-known sports company in South London that&#xD;
      specialise in providing sports coaching for children with additional needs.&#xD;
&#xD;
      End of intervention assessment - parent to complete 2 weeks of sleep diaries for child for&#xD;
      last 2 weeks of intervention, and to complete Likert-scale and free-text questionnaires as&#xD;
      below.&#xD;
&#xD;
      Definition of end of trial:&#xD;
&#xD;
      The trial will end 3 months after the last exercise session, when height and weight are&#xD;
      recorded as the final measure at a face-to-face clinic appointment.&#xD;
&#xD;
      Sample:&#xD;
&#xD;
      This number is limited to the number of children the instructor can teach during a course of&#xD;
      the intervention. The instructor has advised he can teach a maximum of 15 students. Data on&#xD;
      age, gender, ethnicity, weight and medical diagnosis will be recorded&#xD;
&#xD;
      Outcome measures:&#xD;
&#xD;
        1. Acceptability of the intervention with respect to accessibility, journey to venue,&#xD;
           appropriateness, likelihood to recommend to others&#xD;
&#xD;
        2. Attrition rate&#xD;
&#xD;
        3. Sleep diaries will be completed by parents/carers specifically to assess:&#xD;
&#xD;
             -  Bedtime&#xD;
&#xD;
             -  Time fell asleep (to then work out sleep latency/time to fall asleep)&#xD;
&#xD;
             -  Number of night wakings&#xD;
&#xD;
             -  Morning wake-up time&#xD;
&#xD;
             -  Estimated total sleep time per night for 2-weeks pre-intervention, and during the&#xD;
                last 2 weeks of intervention for comparison&#xD;
&#xD;
        4. Parent reported effects on wellbeing of child and family scored on Likert Scale (see&#xD;
           Parent-reported outcome measures, Appendix 1)&#xD;
&#xD;
        5. Measurement of Body Mass Index pre-intervention and at 3-months post-intervention at&#xD;
           face-to-face clinic appointment&#xD;
&#xD;
      Study Timetable:&#xD;
&#xD;
      Month 1: Recruitment Month 2-4: Intervention, 2 sessions weekly for 10 weeks Month 5-7: Data&#xD;
      collection Month 7-9: Data Analysis Month 10-12: Writing up&#xD;
&#xD;
      Eligibility Inclusion criteria&#xD;
&#xD;
        1. Diagnosed neurodevelopmental disability&#xD;
&#xD;
        2. Open to the Lambeth and Southwark Community Sleep Clinic&#xD;
&#xD;
        3. Age range: 5 years 0 months - 15 years 11months. Exclusion criteria&#xD;
&#xD;
      1) High risk safeguarding concerns 2) Health issues where the intervention has the potential&#xD;
      to have an adverse effect on the child e.g. undiagnosed/untreated epilepsy&#xD;
&#xD;
      Criteria and procedures for subject withdrawal or discontinuation.&#xD;
&#xD;
        1. Injury or illness (physical or mental) that prevents the participant engaging in the&#xD;
           activity.&#xD;
&#xD;
        2. Parental choice to remove participant from activity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">January 6, 2020</completion_date>
  <primary_completion_date type="Actual">January 6, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of the exercise intervention to families</measure>
    <time_frame>Collected in three months following end of intervention</time_frame>
    <description>Measured by attrition rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the exercise intervention to families</measure>
    <time_frame>Collected in three months following end of intervention</time_frame>
    <description>Measure by semi-structured questionnaire; how likely would you be to recommend the activity; how accessible was the venue; how appropriate was the activity to your child's needs; any other comments; with 5-point Likert scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact on the sleep pattern of partaking children</measure>
    <time_frame>For 2 weeks prior to intervention, and for last 2 weeks of intervention</time_frame>
    <description>Through sleep diary reporting (bedtime, time fell asleep, number of times woke in night, time of morning waking, estimated total sleep in hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on the child and family's wellbeing</measure>
    <time_frame>Collected within three months following end of intervention</time_frame>
    <description>Through Likert scale reporting by parent for perceived impact on sleep pattern, general wellbeing, mood and behaviour, wellbeing of parent and/or family (made a lot worse, made a bit worse, no change, improved a bit, improved a lot, improved a great deal)</description>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Neurodevelopmental Disorders</condition>
  <condition>Sleep Disorder</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise programme</intervention_name>
    <description>1 session of trampolining/dry sports (1.5 hours) and 1 session of supervised swimming (1.5 hours) per week for 10 weeks.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children aged 5 years to 15 years 11 months attending the Community Sleep Clinic (a&#xD;
        dedicated Sleep Clinic for children with neurodevelopmental disorders); all levels of&#xD;
        disability will be catered for within the exercise intervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diagnosed neurodevelopmental disability Open to the Lambeth and Southwark Community Sleep&#xD;
        Clinic Age range: 5 years 0 months - 15 years 11months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. High risk safeguarding concerns&#xD;
&#xD;
          2. Health issues where the intervention has the potential to have an adverse effect on&#xD;
             the child e.g. undiagnosed/untreated epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE5 8UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 15, 2019</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>children</keyword>
  <keyword>sleep</keyword>
  <keyword>exercise</keyword>
  <keyword>neurodevelopment</keyword>
  <keyword>feasibility</keyword>
  <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>Undecided</sharing_ipd>
    <ipd_description>Supporting data can be made available on request by contacting study lead</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/NCT04416789
org study id: 237572
nct id: NCT04416789
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is a long-standing assumption that physical activity is an effective,
      non-pharmacological approach to improving sleep quality and quantity. However, objective and
      reliable data on this relationship are scarce for children with developmental disabilities.

      Parent burnout in this population is high and there are many barriers to engagement with such
      interventions. This study aims to understand the feasibility of providing an exercise
      intervention for this population, and gathering parental views on the impact of such an
      intervention.

      Depending on the outcome of this feasibilty study, larger scale interventions may be planned
      to further examine the impact of such an intervention.
Exercise in this population:

      The impact of exercise on sleep in children with developmental disabilities is so far
      tentative. Small-scale studies suggest increasing physical activity in children with
      neurodevelopmental disorders leads to increased sleep quality.

      Recommendations from previous research have included that future studies should assess the
      benefit of a longer intervention period, and impact on the wider family. Our study design
      aims to address these two factors.

      Method:

      Feasibility study using a one sample pre-post design.

      Recruitment:

      Participants will be informed of the study during the standard clinic assessment run by the
      Community Paediatricians (Community Sleep Clinic Lambeth and Southwark). A "consent to be
      contacted" letter will be used to facilitate agreement for the research team to contact
      families to discuss the study in more detail. Families will then be contacted by a member of
      the team not directly linked to their care. Information will be given over the phone and the
      family invited to a study information session at which the study will be explained further,
      questions answered, and consent taken for those who wish to take part.

      During and after completion of the intervention all participants will continue through the
      usual treatment pathway.

      Figure one: participant flow diagram:

      Baseline assessment - parent to complete 2 weeks of sleep diaries for child prior to
      intervention; child height and weight measurement.

      Intervention - 1 session of swimming (1.5 hours) and 1 session of trampolining and dry sports
      (1.5 hours) per week for 10 weeks, totalling 20 x 1.5 hours. The intervention will be
      tailored to the level of ability for each participant (i.e. each exercise will have different
      levels of complexity). Details of the specifics of the intervention that will be undertaken
      by the participants is as above. The intervention will be provided by the 'London PE and
      Schools Sport Network'. This company is a well-known sports company in South London that
      specialise in providing sports coaching for children with additional needs.

      End of intervention assessment - parent to complete 2 weeks of sleep diaries for child for
      last 2 weeks of intervention, and to complete Likert-scale and free-text questionnaires as
      below.

      Definition of end of trial:

      The trial will end 3 months after the last exercise session, when height and weight are
      recorded as the final measure at a face-to-face clinic appointment.

      Sample:

      This number is limited to the number of children the instructor can teach during a course of
      the intervention. The instructor has advised he can teach a maximum of 15 students. Data on
      age, gender, ethnicity, weight and medical diagnosis will be recorded

      Outcome measures:

        1. Acceptability of the intervention with respect to accessibility, journey to venue,
           appropriateness, likelihood to recommend to others

        2. Attrition rate

        3. Sleep diaries will be completed by parents/carers specifically to assess:

             -  Bedtime

             -  Time fell asleep (to then work out sleep latency/time to fall asleep)

             -  Number of night wakings

             -  Morning wake-up time

             -  Estimated total sleep time per night for 2-weeks pre-intervention, and during the
                last 2 weeks of intervention for comparison

        4. Parent reported effects on wellbeing of child and family scored on Likert Scale (see
           Parent-reported outcome measures, Appendix 1)

        5. Measurement of Body Mass Index pre-intervention and at 3-months post-intervention at
           face-to-face clinic appointment

      Study Timetable:

      Month 1: Recruitment Month 2-4: Intervention, 2 sessions weekly for 10 weeks Month 5-7: Data
      collection Month 7-9: Data Analysis Month 10-12: Writing up

      Eligibility Inclusion criteria

        1. Diagnosed neurodevelopmental disability

        2. Open to the Lambeth and Southwark Community Sleep Clinic

        3. Age range: 5 years 0 months - 15 years 11months. Exclusion criteria

      1) High risk safeguarding concerns 2) Health issues where the intervention has the potential
      to have an adverse effect on the child e.g. undiagnosed/untreated epilepsy

      Criteria and procedures for subject withdrawal or discontinuation.

        1. Injury or illness (physical or mental) that prevents the participant engaging in the
           activity.

        2. Parental choice to remove participant from activity
observational model: Family-Based
time perspective: Prospective
measure: Acceptability of the exercise intervention to families
time frame: Collected in three months following end of intervention
description: Measured by attrition rate
measure: Acceptability of the exercise intervention to families
time frame: Collected in three months following end of intervention
description: Measure by semi-structured questionnaire; how likely would you be to recommend the activity; how accessible was the venue; how appropriate was the activity to your child's needs; any other comments; with 5-point Likert scale
measure: Impact on the sleep pattern of partaking children
time frame: For 2 weeks prior to intervention, and for last 2 weeks of intervention
description: Through sleep diary reporting (bedtime, time fell asleep, number of times woke in night, time of morning waking, estimated total sleep in hours)
measure: Impact on the child and family's wellbeing
time frame: Collected within three months following end of intervention
description: Through Likert scale reporting by parent for perceived impact on sleep pattern, general wellbeing, mood and behaviour, wellbeing of parent and/or family (made a lot worse, made a bit worse, no change, improved a bit, improved a lot, improved a great deal)
intervention type: Other
intervention name: Exercise programme
description: 1 session of trampolining/dry sports (1.5 hours) and 1 session of supervised swimming (1.5 hours) per week for 10 weeks.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Sleep Wake Disorders
mesh term: Neurodevelopmental Disorders
sharing ipd: Undecided
ipd description: Supporting data can be made available on request by contacting study lead