<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/NCT03805334</url>
  </required_header>
  <id_info>
    <org_study_id>HM20013034</org_study_id>
    <nct_id>NCT03805334</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children</brief_title>
  <official_title>The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth 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>
      The investigators hypothesize that wearing bilateral therapeutic vibrating devices before bed&#xD;
      will result in positive changes in outcome measures related to sleep (e.g., sleep efficiency)&#xD;
      in children who are sensitive to stimuli in their environment (aka sensory over&#xD;
      responsiveness or SOR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research study is determine if providing bilateral alternating&#xD;
      stimulation to the extremities is effective for improving sleep in children with sensory&#xD;
      processing difficulties. The investigators will use Touchpoints to deliver the intervention.&#xD;
      The Touchpoints look like a regular watch, and vibrate at different low level frequencies to&#xD;
      produce a calming effect on the body. More information about Touchpoints can be found here:&#xD;
      https://thetouchpointsolution.com/pages/shop-touchpoints. The investigators hypothesize that&#xD;
      these types of wearable vibrating devices may help children fall asleep faster and possibly&#xD;
      stay asleep longer. This study will allow the research team to test these assumptions.&#xD;
&#xD;
      In this study, each child will be asked to do the following things:&#xD;
&#xD;
        1. Wear an activity tracker watch on their wrist before bed and through the night for 10&#xD;
           days consecutively (Baseline)&#xD;
&#xD;
        2. Wear both the activity tracker watch (wrist) and the Touchpoints (both ankles) before&#xD;
           bed and during sleep for 10 days straight. (Intervention)&#xD;
&#xD;
        3. Wear the activity tracker watch on their wrist before bed and through the night for 10&#xD;
           additional days (post-test)&#xD;
&#xD;
      During the study, the parents will be asked to fill out a brief sleep diary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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 study will use a non-concurrent multiple baseline design (MBD) where subjects will serve as their own control.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short Sensory Profile 2</measure>
    <time_frame>Change from baseline to study completion (~30 days)</time_frame>
    <description>The Short Sensory Profile 2 is a caregiver questionnaire for children ages 3-14 years. It draws questions from the Child Sensory Profile 2 which measures sensory processing on two intersecting scales: high vs. low threshold for responding to sensations and passive vs. active self-regulation in anticipation or response to sensory stimuli. The Short Sensory Profile 2 is primarily used for research and screening purposes while the Child Sensory Profile 2 is for clinical practice. The investigators will use this during the screening phase of the study to determine whether potential participants have sensory processing differences.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Children's Sleep Wake Scale (CSWS)</measure>
    <time_frame>Change from baseline to study completion (~30 days)</time_frame>
    <description>The Children's Sleep-Wake Scale is a caregiver questionnaire for children ages 2-8 years. It covers children's going to bed, falling asleep, arousing and awakening during the night, returning to sleep after awakening during the night, and waking during the morning. The investigators will use this during the screening phase of the study to determine whether potential participants have trouble with sleep behaviors and to assess whether the intervention significantly changed sleep behaviors. The Children's Sleep Wake Scale includes a total of 25 questions that are ranked on a scale of 1 (never) to 6 (always). Five sub-scale scores are derived from this measure (Going to Bed, Falling Asleep, Maintaining Sleep, Re-initiating Sleep, Returning to Wakefulness) as well as a Total Sleep Quality score (mean of all 5 sub-scale scores added together). Both the sub-scales and the total scores are &quot;reverse scored&quot; (e.g., 1=6 and 6=1) so that higher scores equal better sleep quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Efficiency</measure>
    <time_frame>Change from baseline to study completion (~30 days)</time_frame>
    <description>Sleep efficiency is the ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed. Sleep efficiency will be measuring using the ActiGraph GT9X Link, a device that is worn like a watch that measures a person's activity. Efficiency will be reported as a percentage (e.g., 88% sleep efficiency). Scores above 85% are general considered within normal range; however each subject will serve as their own control and improvements will be noted from baseline to post-intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Latency</measure>
    <time_frame>Change from baseline to study completion (~30 days)</time_frame>
    <description>Sleep latency refers to the time (measured in minutes) that it takes for a subject to fall asleep once they have &quot;gone to bed&quot;. Sleep latency will be determined by comparing data that is recorded by the ActiGraph GT9X Link device (activity tracker) with data recorded by parents in the child's Sleep Diary. In the diary, parents will be asked to answer the following question: What time did you (or your child) try to go to sleep? This is usually when you turn the lights out and any devices off. Changes in sleep latency will be compared between baseline and intervention phases as well as at the completion of a post-intervention phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Nighttime Awakenings</measure>
    <time_frame>Change from baseline to study completion (~30 days)</time_frame>
    <description>This is a count variable which will automatically be calculated by the ActiGraph GT9X Link device worn on the child's wrist. The ActiGraph will be programed to count any active movement lasting longer than 10 seconds after sleep has been initiated as a &quot;nighttime awakening&quot;. Total number of night time awakenings will be compared across baseline, intervention, and post-intervention phases.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Sleep</condition>
  <condition>Sensory Disorders</condition>
  <arm_group>
    <arm_group_label>Touchpoints</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will wear Touchpoints devices on both ankles daily for 10 days. The devices will be worn ~1 hour before bedtime and through the night. They will be removed upon waking in the morning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Touchpoints</intervention_name>
    <description>Touchpoints are worn on either the wrists or ankles. They deliver a low level vibration in an alternating fashion to the skin.</description>
    <arm_group_label>Touchpoints</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scores &quot;more than others&quot; in either sensation avoiding or sensory over-responsive on&#xD;
             the Short Sensory Profile&#xD;
&#xD;
          -  Has identified sleep difficulties on the Children's Sleep Wake Scale (any sub-scale&#xD;
             scores outside of normative range)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed seizure disorder or history of seizures&#xD;
&#xD;
          -  Rubber or latex allergy (will not be able to wear wrist band)&#xD;
&#xD;
          -  Significant motor impairments (e.g. cerebral palsy)&#xD;
&#xD;
          -  Children who are wards of the state&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stacey Reynolds, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Katherine Lawrence Dragas Sensory Processing and Stress Evaluation Lab</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>September 18, 2019</last_update_submitted>
  <last_update_submitted_qc>September 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sleep</keyword>
  <keyword>sensory over-responsiveness</keyword>
  <keyword>hypersensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sensation Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT03805334
org study id: HM20013034
nct id: NCT03805334
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesize that wearing bilateral therapeutic vibrating devices before bed
      will result in positive changes in outcome measures related to sleep (e.g., sleep efficiency)
      in children who are sensitive to stimuli in their environment (aka sensory over
      responsiveness or SOR).
The purpose of this research study is determine if providing bilateral alternating
      stimulation to the extremities is effective for improving sleep in children with sensory
      processing difficulties. The investigators will use Touchpoints to deliver the intervention.
      The Touchpoints look like a regular watch, and vibrate at different low level frequencies to
      produce a calming effect on the body. More information about Touchpoints can be found here:
      https://thetouchpointsolution.com/pages/shop-touchpoints. The investigators hypothesize that
      these types of wearable vibrating devices may help children fall asleep faster and possibly
      stay asleep longer. This study will allow the research team to test these assumptions.

      In this study, each child will be asked to do the following things:

        1. Wear an activity tracker watch on their wrist before bed and through the night for 10
           days consecutively (Baseline)

        2. Wear both the activity tracker watch (wrist) and the Touchpoints (both ankles) before
           bed and during sleep for 10 days straight. (Intervention)

        3. Wear the activity tracker watch on their wrist before bed and through the night for 10
           additional days (post-test)

      During the study, the parents will be asked to fill out a brief sleep diary.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study will use a non-concurrent multiple baseline design (MBD) where subjects will serve as their own control.
primary purpose: Treatment
masking: None (Open Label)
measure: Short Sensory Profile 2
time frame: Change from baseline to study completion (~30 days)
description: The Short Sensory Profile 2 is a caregiver questionnaire for children ages 3-14 years. It draws questions from the Child Sensory Profile 2 which measures sensory processing on two intersecting scales: high vs. low threshold for responding to sensations and passive vs. active self-regulation in anticipation or response to sensory stimuli. The Short Sensory Profile 2 is primarily used for research and screening purposes while the Child Sensory Profile 2 is for clinical practice. The investigators will use this during the screening phase of the study to determine whether potential participants have sensory processing differences.
measure: The Children's Sleep Wake Scale (CSWS)
time frame: Change from baseline to study completion (~30 days)
description: The Children's Sleep-Wake Scale is a caregiver questionnaire for children ages 2-8 years. It covers children's going to bed, falling asleep, arousing and awakening during the night, returning to sleep after awakening during the night, and waking during the morning. The investigators will use this during the screening phase of the study to determine whether potential participants have trouble with sleep behaviors and to assess whether the intervention significantly changed sleep behaviors. The Children's Sleep Wake Scale includes a total of 25 questions that are ranked on a scale of 1 (never) to 6 (always). Five sub-scale scores are derived from this measure (Going to Bed, Falling Asleep, Maintaining Sleep, Re-initiating Sleep, Returning to Wakefulness) as well as a Total Sleep Quality score (mean of all 5 sub-scale scores added together). Both the sub-scales and the total scores are "reverse scored" (e.g., 1=6 and 6=1) so that higher scores equal better sleep quality.
measure: Sleep Efficiency
time frame: Change from baseline to study completion (~30 days)
description: Sleep efficiency is the ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed. Sleep efficiency will be measuring using the ActiGraph GT9X Link, a device that is worn like a watch that measures a person's activity. Efficiency will be reported as a percentage (e.g., 88% sleep efficiency). Scores above 85% are general considered within normal range; however each subject will serve as their own control and improvements will be noted from baseline to post-intervention.
measure: Sleep Latency
time frame: Change from baseline to study completion (~30 days)
description: Sleep latency refers to the time (measured in minutes) that it takes for a subject to fall asleep once they have "gone to bed". Sleep latency will be determined by comparing data that is recorded by the ActiGraph GT9X Link device (activity tracker) with data recorded by parents in the child's Sleep Diary. In the diary, parents will be asked to answer the following question: What time did you (or your child) try to go to sleep? This is usually when you turn the lights out and any devices off. Changes in sleep latency will be compared between baseline and intervention phases as well as at the completion of a post-intervention phase.
measure: Number of Nighttime Awakenings
time frame: Change from baseline to study completion (~30 days)
description: This is a count variable which will automatically be calculated by the ActiGraph GT9X Link device worn on the child's wrist. The ActiGraph will be programed to count any active movement lasting longer than 10 seconds after sleep has been initiated as a "nighttime awakening". Total number of night time awakenings will be compared across baseline, intervention, and post-intervention phases.
arm group label: Touchpoints
arm group type: Experimental
description: Subjects will wear Touchpoints devices on both ankles daily for 10 days. The devices will be worn ~1 hour before bedtime and through the night. They will be removed upon waking in the morning.
intervention type: Other
intervention name: Touchpoints
description: Touchpoints are worn on either the wrists or ankles. They deliver a low level vibration in an alternating fashion to the skin.
arm group label: Touchpoints
criteria: 
gender: All
minimum age: 3 Years
maximum age: 8 Years
healthy volunteers: No
last name: Stacey Reynolds, PhD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sensation Disorders