Attention Deficit Disorder With HyperactivityNCT05308706
Efficacy of the Apollo System for Children With ADHD
A study testing 8 weeks of home based use. in people with Attention Deficit Disorder With Hyperactivity, run by Michigan State University at 1 site in United States.
Trial summary
To determine the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- 8 weeks of home based use.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2022to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
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:
- Participants must be 8 years of age or older and under the age of 18.
- Participants must have diagnosed or suspected Attention Deficit Hyperactivity Disorder (ADHD).
- 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.
- 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:
- Lack of consent.
- Participants cannot have started a new treatment within the last 30 days.
- 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.
- Participants cannot have previously used the Apollo System.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology
East Lansing, Michigan, 48824
About this study
Official title: Double-blind Randomized Placebo-controlled Trial of the Efficacy of the Apollo System for Children With ADHD
To determine the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.
Read the 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.
- Being tested
- 8 weeks of home based use.
- Keywords
- ADHD, Inhibition, Vibrational therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 weeks of home based use.Device
Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.
| Study group | Role | What they receive |
|---|---|---|
| Commercial Apollo System Device | Experimental | The active experimental group received the commercial Apollo System device. Receives: Device: 8 weeks of home based use. |
| Sham Apollo System Device | Sham comparator | 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. Receives: Device: 8 weeks of home based use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale
At pre and posttest, the parents/guardians of participants will complete the ADHD-5 Rating Scale. The behaviors included in the survey are derived from the diagnostic criteria for ADHD established in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. Scores are summated into inattentive and hyperactive-impulsive symptom domains and transformed into symptom percentile scores based upon normative data based on age and biological sex. Change in the overall ADHD percentile will be considered as the primary outcome. A more negative change would indicate a better outcome reflective of reduction in ADHD related symptomatology.
Measured: Prior to and following the 8 week study protocol period.
Effect Size for Change in Behavioral Index of Interference Control
At pre and posttest, participants will complete a version of the Eriksen flanker task. Response accuracy will be quantified within each congruency as the proportion of correct responses relative to the number of trials administered. The effect size of the change from pre-to-posttest in overall response accuracy will be considered as the primary outcome.
Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013).
Measured: Prior to and following the 8 week study protocol period.
Effect Size for Change in Behavioral Index of Response Inhibition
At pre and posttest, participants will complete a version of the go/nogo task. Response accuracy will be quantified as the proportion of correct responses relative to the number of trials administered for target stimulus trails and nogo stimulus trials separately. The effect size of the change from pre-to-posttest for response accuracy to the nogo condition will be considered as the primary outcome.
Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013).
Measured: Prior to and following the 8 week study protocol period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start18 Mar 2022
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- The Board of Medicine
- Responsible party
- Principal investigator, Matthew B. Pontifex, Ph.D., Michigan State University
- Investigators
- Matthew B Pontifex, PhD., Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308706
- Sponsor's protocol ID
- STUDY00005951
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Placebo-controlled Trial of the Efficacy of the Apollo System for Children With ADHD
- ClinicalTrials.gov ID
- NCT05308706
- Acronym / sponsor ID
- STUDY00005951
- Keywords
- ADHD, Inhibition, Vibrational therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- The Board of Medicine
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Commercial Apollo System Device | Experimental | Device: 8 weeks of home based use.The active experimental group received the commercial Apollo System device. |
| Sham Apollo System Device | Sham comparator | Device: 8 weeks of home based use.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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Commercial Apollo System Device, Sham Apollo System Device |
Primary outcome
Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale
Time frame: Prior to and following the 8 week study protocol period.
At pre and posttest, the parents/guardians of participants will complete the ADHD-5 Rating Scale. The behaviors included in the survey are derived from the diagnostic criteria for ADHD established in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. Scores are summated into inattentive and hyperactive-impulsive symptom domains and transformed into symptom percentile scores based upon normative data based on age and biological sex. Change in the overall ADHD percentile will be considered as the primary outcome. A more negative change would indicate a better outcome reflective of reduction in ADHD related symptomatology.
Effect Size for Change in Behavioral Index of Interference Control
Time frame: Prior to and following the 8 week study protocol period.
At pre and posttest, participants will complete a version of the Eriksen flanker task. Response accuracy will be quantified within each congruency as the proportion of correct responses relative to the number of trials administered. The effect size of the change from pre-to-posttest in overall response accuracy will be considered as the primary outcome. Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013).
Effect Size for Change in Behavioral Index of Response Inhibition
Time frame: Prior to and following the 8 week study protocol period.
At pre and posttest, participants will complete a version of the go/nogo task. Response accuracy will be quantified as the proportion of correct responses relative to the number of trials administered for target stimulus trails and nogo stimulus trials separately. The effect size of the change from pre-to-posttest for response accuracy to the nogo condition will be considered as the primary outcome. Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew B Pontifex, PhD. principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8 weeks of home based use. in people with Attention Deficit Disorder With Hyperactivity, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale (time frame: Prior to and following the 8 week study protocol period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.