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

NCT03805334 | Completed

• 1 other identifier: HM20013034
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep; Sensory Disorders

Keywords

sleep; sensory over-responsiveness; hypersensitivity

Outcome Measures

Primary Outcomes (5)

• 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.

  Change from baseline to study completion (~30 days)

• 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.

  Change from baseline to study completion (~30 days)

• 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.

  Change from baseline to study completion (~30 days)

• 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.

  Change from baseline to study completion (~30 days)

• 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.

  Change from baseline to study completion (~30 days)

Study Arms (1)

Touchpoints

EXPERIMENTAL

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.

Other: Touchpoints

Interventions

Touchpoints OTHER

Touchpoints are worn on either the wrists or ankles. They deliver a low level vibration in an alternating fashion to the skin.

Touchpoints

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Katherine Lawrence Dragas Sensory Processing and Stress Evaluation Lab

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Sensation Disorders; Hypersensitivity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Stacey Reynolds, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will use a non-concurrent multiple baseline design (MBD) where subjects will serve as their own control.

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 15, 2019
• Study Start: February 12, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

US (1)