Apollo Neuro Device for Autism

LL
Overseen ByLaura Lee Robins
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Virginia Commonwealth University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

SR

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

Child presence of self-injurious behavior, as reported by caregiver
Child demonstrates sensory over and/or under-responsivity
Child has a caregiver willing and able to provide consent and participate in study procedures
See 6 more

Exclusion Criteria

Child has known seizure disorder without physician clearance
My child has serious heart problems or irregular heartbeats.
My child has a history of fainting.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear the Apollo Neuro device for at least 3 hours per day over a 30-35 day period with caregiver support

4-5 weeks
Daily monitoring by caregivers

Follow-up

Participants are monitored for adherence, feasibility, and acceptability of the device use

2 weeks

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

Group I: Apollo Neuro deviceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials
732
Recruited
22,900,000+

Citations

Pilot 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 ...

Using Apollo Neuro in Autistic Children... | Clinical Trial

Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver- ...

Apollo 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.

Pilot 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.

Apollo 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 ...

Apollo 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.

87 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 ...