The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children
Primary Purpose
Sleep, Sensory Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Touchpoints
Sponsored by
About this trial
This is an interventional treatment trial for Sleep focused on measuring sleep, sensory over-responsiveness, hypersensitivity
Eligibility Criteria
Inclusion Criteria:
- Scores "more than others" in either sensation avoiding or sensory over-responsive on the Short Sensory Profile
- Has identified sleep difficulties on the Children's Sleep Wake Scale (any sub-scale scores outside of normative range)
Exclusion Criteria:
- Diagnosed seizure disorder or history of seizures
- Rubber or latex allergy (will not be able to wear wrist band)
- Significant motor impairments (e.g. cerebral palsy)
- Children who are wards of the state
Sites / Locations
- Katherine Lawrence Dragas Sensory Processing and Stress Evaluation Lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Touchpoints
Arm 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.
Outcomes
Primary Outcome Measures
Short Sensory Profile 2
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.
The Children's Sleep Wake Scale (CSWS)
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.
Sleep Efficiency
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.
Sleep Latency
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.
Number of Nighttime Awakenings
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03805334
First Posted
December 19, 2018
Last Updated
September 18, 2019
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03805334
Brief Title
The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children
Official Title
The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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:
Wear an activity tracker watch on their wrist before bed and through the night for 10 days consecutively (Baseline)
Wear both the activity tracker watch (wrist) and the Touchpoints (both ankles) before bed and during sleep for 10 days straight. (Intervention)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Sensory Disorders
Keywords
sleep, sensory over-responsiveness, hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will use a non-concurrent multiple baseline design (MBD) where subjects will serve as their own control.
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Touchpoints
Arm Type
Experimental
Arm 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(s)
Touchpoints
Intervention Description
Touchpoints are worn on either the wrists or ankles. They deliver a low level vibration in an alternating fashion to the skin.
Primary Outcome Measure Information:
Title
Short Sensory Profile 2
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.
Time Frame
Change from baseline to study completion (~30 days)
Title
The Children's Sleep Wake Scale (CSWS)
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.
Time Frame
Change from baseline to study completion (~30 days)
Title
Sleep Efficiency
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.
Time Frame
Change from baseline to study completion (~30 days)
Title
Sleep Latency
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.
Time Frame
Change from baseline to study completion (~30 days)
Title
Number of Nighttime Awakenings
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.
Time Frame
Change from baseline to study completion (~30 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scores "more than others" in either sensation avoiding or sensory over-responsive on the Short Sensory Profile
Has identified sleep difficulties on the Children's Sleep Wake Scale (any sub-scale scores outside of normative range)
Exclusion Criteria:
Diagnosed seizure disorder or history of seizures
Rubber or latex allergy (will not be able to wear wrist band)
Significant motor impairments (e.g. cerebral palsy)
Children who are wards of the state
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey Reynolds, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katherine Lawrence Dragas Sensory Processing and Stress Evaluation Lab
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
12. IPD Sharing Statement
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The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children
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