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

NCT05077722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Paul Croarkin, DO, MS · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077722 on ClinicalTrials.gov