Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-02-11 @ 1:17 PM
Study NCT ID:
NCT03805334
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2018-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: