Apollo Neuro Device for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a wearable device called Apollo Neuro to determine its potential benefits for autistic children who engage in self-injurious behavior (SIB). The device aims to address sensory issues, which autistic individuals often experience. Participants will wear the device for at least three hours daily over a month, with caregiver assistance. Children diagnosed with autism, who exhibit self-injurious behavior, and experience sensory over- or under-responsivity might be suitable candidates. The primary goal is to assess the device's ease of use and acceptability, not its effectiveness. As an unphased trial, this study provides a unique opportunity for participants to contribute to early research on innovative solutions for sensory issues.
What prior data suggests that the Apollo Neuro device is safe for autistic children?
Research has shown that the Apollo Neuro device, a wearable gadget using gentle vibrations, is safe for users. In several trials, participants reported improvements in mood, behavior, and stress reduction without any negative effects. Healthcare professionals have also used the device, experiencing significant stress reduction. For instance, a group of nurses saw their stress scores drop by over 40% in just two weeks.
Further research confirms the safety of the Apollo Neuro, with its technology reviewed in over a dozen independent studies. These studies consistently show that most users tolerate the device well. While these results are encouraging, prospective trial participants should discuss potential risks with their healthcare provider.12345Why are researchers excited about this trial?
Unlike traditional treatments for autism, which often include behavioral therapy and medication, the Apollo Neuro device introduces a unique approach by using wearable technology to potentially ease symptoms. This device utilizes gentle vibrations that may help regulate the nervous system, offering a new mechanism of action compared to existing options. Researchers are excited about this non-invasive and user-friendly method because it might provide relief without the side effects often associated with medication, giving children and their families a new avenue to explore for managing sensory challenges and self-injurious behavior.
What evidence suggests that the Apollo Neuro device is effective for autism?
Research has shown that the Apollo Neuro device might improve mood and behavior. In earlier studies, all participants experienced better mood and behavior, with 9 out of 10 becoming more engaged. The device aims to help manage stress, which can be challenging for autistic children, by using gentle vibrations to ease overwhelming sensory experiences. Another study found that stress levels in adults dropped by over 40%, with improvements in sleep, mood, and focus. While these results are encouraging, this trial will specifically evaluate the device's effects on autistic children with self-injurious behavior and sensory over- or under-responsivity.26789
Who Is on the Research Team?
Stacey Reynolds
Principal Investigator
Virginia Commonwealth University
Are You a Good Fit for This Trial?
This trial is for autistic children who engage in self-injurious behaviors. Participants need to be able to wear a sensory device on their body daily with caregiver support. Other specific inclusion or exclusion criteria are not listed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants wear the Apollo Neuro device for at least 3 hours per day over a 30-35 day period with caregiver support
Follow-up
Participants are monitored for adherence, feasibility, and acceptability of the device use
What Are the Treatments Tested in This Trial?
Interventions
- Apollo Neuro device
Trial Overview
The study tests the use of the Apollo Neuro, a wearable device that delivers gentle vibrations, to see if it is practical and acceptable for autistic children with self-harm behaviors. All participants will use the device daily for about one month.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Wearing of activated Apollo Neuro device for at least three hours/day for 30 of 35 consecutive days by Autistic children with SIB and sensory over and/or under responsivity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor
Citations
1.
apolloneuro.com
apolloneuro.com/blogs/news/positive-impact-on-pediatrics-with-anxiety-and-adhd?srsltid=AfmBOopu-JAaa78b7p2X-7Pw5-5InSiuzkIkykha5p5JqguBKlI3SSy4Pilot study validates the Apollo wearable's positive impact ...
The Apollo wearable showed measurable improvements in mood, behavior, engagement, and stress reduction within minutes in all participants.
Using Apollo Neuro in Autistic Children With Self-Injurious ...
This study will evaluate the feasibility and acceptability of the Apollo Neuro, a wearable vibrotactile sensory device, in autistic children who ...
3.
trial.medpath.com
trial.medpath.com/clinical-trial/6c221a1727a4068f/nct07648420-apollo-neuro-wearable-sensory-device-autistic-children-self-injurious-behaviorUsing Apollo Neuro in Autistic Children... | Clinical Trial
Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver- ...
4.
apolloneuro.com
apolloneuro.com/pages/apollo-neuro-research?srsltid=AfmBOoqM5mElq3t2DFBoihi2hDeTG-YyPdCGXABTG2u646Ym54kKOMBhApollo Neuro Research
100% of patients showed improvements in mood and behavior 9 out of 10 patients showed improvement in engagement 50% reduction in stress score
Commercial Wearables for the Management of People ... - PMC
Apollo Neuro, which uses gentle vibrations or calming sounds, are beneficial for managing responses to overwhelming sensory stimuli.
6.
apolloneuro.com
apolloneuro.com/blogs/news/positive-impact-on-pediatrics-with-anxiety-and-adhd?srsltid\u003dAfmBOorNeo4D8hHhqM1SnoAlOvpq4lgB8zQhryyb43rDgg3G7iI_Q3msPilot study validates the Apollo wearable's positive impact ...
The Apollo wearable showed measurable improvements in mood, behavior, engagement, and stress reduction within minutes in all participants.
7.
apolloneuro.com
apolloneuro.com/pages/apollo-neuro-research?srsltid\u003dAfmBOoqa1NEchknizdD0NseoU6xNFj5E-DrJXFxTwRNS8s8rTDEOJ1jeApollo Neuro Research
The Apollo technology's efficacy and safety have been validated in over a dozen independent and university-led trials, and there are more studies in progress ...
8.
apolloneuro.com
apolloneuro.com/?srsltid\u003dAfmBOoqWIAq6ppZiobUQZkruBf1ydnLaV2MLfyAahrDR48Mbqgk2l9DfApollo Neuro: Touch Therapy Tech for Stress, Sleep ...
By utilizing the power of touch, Apollo trains your nervous system to cope with stress better over time – so you can access your most optimal state more often.
9.
withpower.com
withpower.com/clinical-trials/for-autism-near-miami-fl?new\u003dtrue\u0026page\u003d387 Autism Trials near Miami, FL
This study will evaluate the feasibility and acceptability of the Apollo Neuro, a wearable vibrotactile sensory device, in autistic children who engage in self ...
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