The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Sensory Disorders; Sleep

Treatments: Other: Touchpoints

Study type: Interventional

Funder types: Other

Identifiers

NCT03805334

HM20013034

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Touchpoints

Experimental group

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.

Treatment:

Other: Touchpoints