NCT05077722

Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence

PISTACHIO (Preemption Of Disruptive Behavior In Children) Real-Time Monitoring Of Sleep And Behavior Of Children 3-7-Year-Old Receiving Parent Child Interaction Therapy Augmented With Artificial Intelligence Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 3 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to develop an innovative wearable tracking protocol that will use Artificial Intelligence (AI) technology to monitor sleep and behavior of 3-7 year old children.

Conditions

• Disruptive Behavior
• Attention-deficit Hyperactivity
• Oppositional Defiant Disorder

Interventions

Type	Name	Description
DEVICE	Garmin	A smartwatch device that measures subjects level of activity, heartrate, respirations and quality of your sleep at night. Artificial intelligence will be applied to analyze all the data over the course of 12 weeks to monitor and attempt to predict the onset of tantrums or disruptive behavior. Subjects are required to wear the watch at least 70% of the day and night each day for 70% of days during 12 weeks of treatment.

Timeline

• Start date: 2022-03-24
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-10-14
• Last updated: 2024-03-22

Locations

1 site across 1 country: United States