Clinical trial NCT03805334: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Sensory Disorders
Keywords: sleep
sensory over-responsiveness
hypersensitivity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 3
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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:

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.

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

Primary outcomes:
measure: Short Sensory Profile 2
timeFrame: Change from baseline to study completion (~30 days)
measure: The Children's Sleep Wake Scale (CSWS)
timeFrame: Change from baseline to study completion (~30 days)
measure: Sleep Efficiency
timeFrame: Change from baseline to study completion (~30 days)
measure: Sleep Latency
timeFrame: Change from baseline to study completion (~30 days)
measure: Number of Nighttime Awakenings
timeFrame: Change from baseline to study completion (~30 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Katherine Lawrence Dragas Sensory Processing and Stress Evaluation Lab
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Stacey Reynolds, PhD
role: PRINCIPAL_INVESTIGATOR
References: