NCT05308706

Efficacy of the Apollo System for Children With ADHD

Double-blind Randomized Placebo-controlled Trial of the Efficacy of the Apollo System for Children With ADHD

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Michigan State University · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

To determine the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.

Detailed description

The objective of this project is to understand the potential therapeutic benefits of the Apollo System for children with ADHD. Using vibrational therapy, the Apollo System has been previously demonstrated to promote greater balance of the autonomic nervous system. Given the importance of the autonomic nervous system for modulating levels of physiological arousal and in-turn governing aspects of attention and self-regulation; a therapeutic approach to promote better balance of this system may be particularly beneficial for populations such as children with ADHD. Accordingly, using a double-blind randomized placebo-controlled design this investigation will assess the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DEVICE	8 weeks of home based use.	Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.

Timeline

• Start date: 2022-03-18
• Primary completion: 2024-08-15
• Completion: 2024-08-15
• First posted: 2022-04-04
• Last updated: 2022-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study