Efficacy of the Apollo System for Children With ADHD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-18

Study Completion Date

2024-08-15

Brief Summary

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

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Detailed Description

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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

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All participants receive an Apollo System device. However, participants are randomly assigned to receive a device that uses the current pattern of vibrations as in the commercial Apollo System device or receive a device that uses an ultra-low frequency pattern of vibrations (sham device).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Double blind, sham/placebo controlled trial.

Study Groups

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Commercial Apollo System Device

The active experimental group received the commercial Apollo System device.

Group Type EXPERIMENTAL

8 weeks of home based use.

Intervention Type DEVICE

Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.

Sham Apollo System Device

The control experimental group received a sham/placebo device that is identical to the commercial Apollo System device but uses an ultra-low (i.e., effectively zero) frequency pattern of vibrations.

Group Type SHAM_COMPARATOR

8 weeks of home based use.

Intervention Type DEVICE

Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No