NCT05710965

Assessing a Wearable Digital Therapy for Youth With ADHD

A Randomized Controlled Intervention Study to Assess a Wearable Digital Therapy for Youth With ADHD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Revibe Technologies · Industry
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate and compare three different investigational wearable digital interventions to determine if they are helpful for improving symptoms and functioning in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed description

The study is a randomized controlled trial of three investigational wearable digital therapies. An online screening questionnaire will evaluate eligibility for the study. Parents and teachers will complete baseline measures, after which the child will wear the assigned device to school Monday-Friday for a four-week period. Parents and teachers will complete the measures again at the end of the four-week intervention period. Compliance with wearing the device will be monitored remotely.

Conditions

• ADHD

Interventions

Type	Name	Description
DEVICE	FRx-001	Wearable digital therapy
DEVICE	FRx-003	Wearable digital therapy
DEVICE	FRx-004	Wearable digital therapy

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-06-09
• Completion: 2023-06-09
• First posted: 2023-02-02
• Last updated: 2023-06-13

Locations

1 site across 1 country: United States