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Efficacy of the Apollo System for Children With ADHD

Efficacy of the Apollo System for Children With ADHD

Non Recruiting
8-17 years
All
Phase N/A

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Overview

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

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.

Eligibility

Inclusion Criteria: All individuals that agreed to participate will be selected on a first

        come, first serve basis. No individual will be turned down due to sex, race, or ethnicity.
        The following inclusion criteria exist for all participants:
          1. Participants must be 8 years of age or older and under the age of 18.
          2. Participants must have diagnosed or suspected Attention Deficit Hyperactivity Disorder
             (ADHD).
          3. Participants must have one of the following: 1) on the same treatment plan for over a
             year with minimal symptom relieve or alleviation, 2) tried two or more treatment
             approaches but is unable to meet treatment goals, 3) taking medication but still has
             symptoms, or 4) unwanted or uncontrollable side effects related to the medication.
          4. Participants must have normal or corrected-to-normal vision in order to complete the
             cognitive task.
        Exclusion Criteria: The following exclusion criteria exist for all participants:
          1. Lack of consent.
          2. Participants cannot have started a new treatment within the last 30 days.
          3. Participants cannot have a history of hydrocephalus, Autism Spectrum Disorder,
             Schizophrenia, Conduct disorder, Oppositional Defiant Disorder, active substance
             abuse, or be on a beta blocker.
          4. Participants cannot have previously used the Apollo System.

Study details
    Attention Deficit Disorder With Hyperactivity

NCT05308706

Michigan State University

20 August 2025

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