Apollo Wearable for Burnout

Overseen By Franchesca Inay, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Own Apollo device, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a wearable device, the Apollo Wearable, can help reduce burnout in physicians. The Apollo device emits gentle vibrations that may improve mood, boost energy, and sharpen focus. The study targets physicians and residents from UPMC who feel burned out or overwhelmed. Participants must have an iOS or Android phone and should not already own an Apollo device. As an unphased trial, this study allows participants to explore innovative solutions for burnout without the constraints of traditional clinical trial phases.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Apollo Wearable is safe for use in physicians?

Research has shown that the Apollo wearable device, which emits gentle vibrations, can enhance well-being and reduce burnout. Over a dozen independent and university-led studies have tested this technology, supporting its safety and effectiveness for people.

The device sends tiny vibrations through the skin, designed to be just noticeable for comfort. Participants can adjust the intensity to their preference. Other research has demonstrated the safety of similar devices.

Although specific safety details from these studies aren't highlighted, testing in numerous trials suggests the device is generally well-tolerated by users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Apollo Wearable for burnout because it uses a unique approach called Transcutaneous Vibratory Stimulation (TVS), which delivers gentle vibrations to the body. Unlike traditional treatments for burnout, which might involve medication or therapy, the Apollo Wearable offers a non-invasive and drug-free method that targets the sensory threshold. This could make it a safer and more comfortable option for users, who can also adjust the intensity of the vibrations to their liking. The ability to manage stress and burnout through wearable technology offers a novel, user-controlled solution that sets it apart from existing treatments.

What evidence suggests that the Apollo Wearable is effective for burnout?

Research shows that the Apollo wearable device, which participants in this trial will use, might help reduce burnout and improve well-being. Studies have found clear improvements in stress and burnout levels among users. Specifically, health professionals and medical students using the device reported feeling less stressed and generally better. The device sends gentle vibrations that can boost mood, energy, and focus. These early results suggest that the Apollo device could be a useful tool for managing burnout. ^{1 6 7 8 9}

Who Is on the Research Team?

Michelle Thompson, DO

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for UPMC attending physicians and residents experiencing burnout. Participants must have an iOS or Android phone to join. Those who already own an Apollo device or are unwilling/unable to participate in the study cannot join.

Inclusion Criteria

UPMC attending physicians and residents

Participants must have either IOS or Android phones

Exclusion Criteria

I am willing and able to participate in the study.

Currently own an Apollo device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Physicians wear the Apollo device for heart rate variability modulation and complete questionnaires before and after use

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Apollo Wearable

Trial Overview The study is testing the Apollo Wearable, a device that emits vibrations aimed at improving mood, energy, and focus. The goal is to see if it can help reduce feelings of burnout among physicians.

How Is the Trial Designed?

Group I: Apollo Intervention Arm Experimental Treatment 1 Intervention

Eligible UPMC Physicians and Residents who consent to be part of this study will use an Apollo Device TVS (10-200 Hz) attached to the subject's wrist or ankle via a commercially available wearable vibration technology that can deliver TVS (Transcutaneous Vibratory Stimulation). The intensity will be targeted for the sensory threshold (the level at which the vibration is just noticeable), as this is where the TVS seems most effective from prior studies. Similar vibratory stimuli have been demonstrated to be safe in the literature. The intensity of the vibration will be adjusted to the subjects' comfort and can be controlled by the subject at any time.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Michelle Thompson

Lead Sponsor

Trials

1

Recruited

300+

Apollo Neuroscience, Inc.

Industry Sponsor

Trials

5

Recruited

730+

The Board of Medicine

Collaborator

Trials

3

Recruited

600+

The Board of Medicine

Collaborator

Trials

4

Recruited

800+

Published Research Related to This Trial

Wearable technology and predictive algorithms show high accuracy in predicting core body temperature (CBT), with 17 out of 18 algorithms meeting clinical validity standards, which could help prevent heat-related illnesses (HRI) in high-intensity environments.

Despite the promising results, most algorithms do not account for individual and environmental factors that affect CBT, indicating a need for more personalized and robust machine learning methods to enhance prediction accuracy and improve intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Sensor Technology to Predict Core Body Temperature: A Systematic Review. Dolson, CM., Harlow, ER., Phelan, DM., et al.[2023]

Wearable performance devices, such as GPS and accelerometers, allow athletes and healthcare professionals to monitor real-time physiological and movement parameters, which can help optimize training and reduce injury risk.

Despite their potential, the current evidence supporting the effectiveness of these devices in professional sports is limited, indicating a need for further research to develop standardized training protocols based on the data collected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Performance Devices in Sports Medicine. Li, RT., Kling, SR., Salata, MJ., et al.[2018]

The study shows that using safe actuation methods like music, coffee, and perfume can effectively regulate cognitive arousal and enhance performance in tasks requiring working memory, as demonstrated through human-subject experiments.

By utilizing wearable devices to monitor brain states, the research contributes valuable data for future machine learning applications aimed at creating personalized systems for managing cognitive states and improving overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation of brain cognitive states through auditory, gustatory, and olfactory stimulation with wearable monitoring. Fekri Azgomi, H., F Branco, LR., Amin, MR., et al.[2023]

The phybrata sensor, used in a study of 175 patients over 12 months, effectively distinguishes between individuals with concussions and those without, showing over 90% accuracy in diagnosing neurological and vestibular impairments associated with concussions.

This technology not only aids in the objective diagnosis of concussions but also helps track recovery and tailor rehabilitation strategies, making it a valuable tool alongside traditional assessment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological Vibration Acceleration (Phybrata) Sensor Assessment of Multi-System Physiological Impairments and Sensory Reweighting Following Concussion. Ralston, JD., Raina, A., Benson, BW., et al.[2022]

Wearable devices that monitor brain signals raise significant privacy concerns, particularly regarding how data is collected and managed.

Industry experts highlighted issues related to user autonomy, the need for transparency in information sharing, and the unique nature of brain data, suggesting that current regulatory systems may not adequately address these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Privacy Challenges to the Democratization of Brain Data. Minielly, N., Hrincu, V., Illes, J.[2021]

Motion-based biomarkers, such as patterns of movement and gait analysis, can provide valuable insights into health and physiological status, with technologies now able to quantify physical activity and predict injury risks.

Wearable systems and smart technologies are advancing the ability to monitor health conditions like depression and movement disorders, allowing for earlier identification and better management of chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

With life there is motion. Activity biomarkers signal important health and performance outcomes. Friedl, KE., Looney, DP.[2023]

The Critical Path Institute's Electronic Patient-Reported Outcome Consortium has developed recommendations for selecting and evaluating wearable devices in clinical trials, emphasizing the need for fit-for-purpose wearables that can reliably collect data for regulatory purposes.

The report outlines essential properties and evidence required to support the use of wearables in clinical endpoints, aiming to enhance regulatory guidance and promote their appropriate integration into study protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium. Byrom, B., Watson, C., Doll, H., et al.[2019]

Wearable inertial sensors can effectively monitor motor activities in individuals with mobility impairments in their everyday environments, providing valuable data that complements traditional clinical assessments.

This systematic review aims to identify and evaluate various outcome measures and data processing algorithms used with these sensors, highlighting the need for standardized approaches to improve the reliability and applicability of the data collected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol of a systematic review on the application of wearable inertial sensors to quantify everyday life motor activity in people with mobility impairments. Rast, FM., Labruyère, R.[2019]

Wearable digital devices, like the Phillips Actiwatch and Preventice BodyGuardian, can effectively collect continuous health data, achieving a high data collection rate of 96% for mobility and sleep, and 80% for heart rate and respiratory monitoring during a phase I clinical trial.

The BodyGuardian device demonstrated a strong correlation with in-clinic heart rate measurements (r = 0.99), effectively capturing heart rate responses to an amphetamine challenge during physical activity, highlighting its potential for real-time monitoring of physiological changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Monitoring Using a Wearable Device Detects Activity-Induced Heart Rate Changes After Administration of Amphetamine. Izmailova, ES., McLean, IL., Hather, G., et al.[2023]

Recent advancements in noninvasive sensor technologies allow for personalized predictions of safe thermal-work limits for soldiers and athletes, enhancing performance and safety during physically demanding tasks.

By combining core temperature estimations from heart rate data with adaptive physiological strain indexes, these technologies can provide real-time monitoring and optimize work-rest schedules, which is particularly beneficial in extreme conditions like wearing protective suits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable physiological monitoring for human thermal-work strain optimization. Buller, MJ., Welles, AP., Friedl, KE.[2019]

Recent advancements in wearable technology are enhancing the assessment of rehabilitation interventions by providing real-time data on patients' activity levels and exercise compliance outside of clinical settings.

These wearable sensors allow healthcare providers to monitor patients' progress more effectively, facilitating better medication management and evaluation of motor activity performance in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of wearable technology. Bonato, P.[2020]

Both healthy individuals and those with neurological impairments showed increased oxygen consumption (VO2) during exercises in a robotic exoskeleton, indicating that this therapy is not passive and requires energy expenditure.

After 12 weeks of robotic therapy, participants with stroke experienced a significant improvement in VO2 levels, while those with multiple sclerosis did not show similar benefits, suggesting that stroke patients may gain more from this type of rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Metabolic Cost of Exercising With a Robotic Exoskeleton: A Comparison of Healthy and Neurologically Impaired People. Postol, N., Lamond, S., Galloway, M., et al.[2021]

The ALAMEDA project utilizes a combination of wearable devices and patient-reported outcomes to continuously collect health data from patients with Parkinson's disease, multiple sclerosis, and stroke over a year, enhancing the understanding of their health status.

The study introduces innovative AI-first analysis methods that leverage this data to predict motor, sleep, emotional, and quality-of-life outcomes, aiming to improve patient engagement and compliance in monitoring neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring and Predicting Health Status in Neurological Patients: The ALAMEDA Data Collection Protocol. Sorici, A., Băjenaru, L., Mocanu, IG., et al.[2023]

A scoping review identified 35 unique wearable technology products for monitoring various aspects of multiple sclerosis (MS), including gait, cognition, and mood, highlighting the potential for continuous and remote patient monitoring.

Despite the variety of available solutions, there is currently no consensus on the best wearable technology for use in MS research or clinical practice, indicating a need for further evaluation of factors like scalability, cost, and accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable technologies to measure clinical outcomes in multiple sclerosis: A scoping review. Alexander, S., Peryer, G., Gray, E., et al.[2023]

Citations

1. amjmed.com amjmed.com/article/S0002-9343(25)00544-3/fulltext

Evaluating the impact of Apollo Neuro™ wearable on ... Preliminary efficacy of reducing burnout, reducing perceived stress, and improving overall wellbeing among participants was measured by ...

2. apolloneuro.com apolloneuro.com/pages/apollo-neuro-research?srsltid=AfmBOopXQJLdYwsN9z1vK-RuYaHuyxIkyxeHh-XTyfJKTEx4rvau9-Ic

Apollo Neuro Research Statistically significant improvements in stress, burnout scores, and wellbeing were observed as assessed by clinically validated assessment tools including the ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40816518/

Evaluating the impact of Apollo Neuro™ wearable on ... Conclusions: AN appears to be a feasible, efficacious tool for reducing burnout and improving wellbeing in health professional students, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395625005552

The effect of the Apollo Neuro device on anxiety among ... The primary outcome measure was the change in Generalized Anxiety Disorder 7-item (GAD-7) scores, calculated as the difference between pre-GAD-7 and post-GAD-7 ...

5. research.wsu.edu research.wsu.edu/news/wsu-researchers-study-wearable-technology-to-reduce-burnout-in-health-sciences-students

WSU Researchers Study Wearable Technology to Reduce ... A WSU study found that the Apollo Neuro™ therapeutic wearable may reduce burnout and improve wellbeing in medical and pharmacy students.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002934325005443

Evaluating the impact of Apollo Neuro™ wearable on ... Overall, our data show that the AN device can improve wellbeing measures, burnout scores, and, potentially, alleviate stress in MD and ...

7. apolloneuro.com apolloneuro.com/pages/apollo-neuro-research?srsltid=AfmBOooLvdT54zn2BATer1zTIMTbvuiXb5B4u-6K6zyi9gsmUGSrZNud

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 ...

8. prnewswire.com prnewswire.com/news-releases/new-study-shows-apollo-neuro-wearable-significantly-reduces-burnout-in-medical-and-pharmacy-students-302545247.html

New Study Shows Apollo Neuro™ Wearable Significantly ... The Apollo Neuro wearable reduced burnout by 32% in 12 weeks. Post ... safety response. Developed by neuroscientists and physicians ...

9. withpower.com withpower.com/trial/phase-burnout-professional-2-2023-65436

Apollo Wearable for Burnout · Info for Participants Is the Apollo Wearable safe for human use? The research articles provided do not contain specific safety data for the Apollo Wearable or similar devices.