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How We鈥檙e Revolutionizing Real-World and Clinical Research With Wearables

How We鈥檙e Revolutionizing Real-World and Clinical Research With Wearables

Here at Apollo Neuro, we are huge fans of the scientific method. We could not be more proud of our clinical research team for all their hard work over the last decade. Since we began developing and researching the technology behind Apollo Neuro at the University of Pittsburgh in 2014, we have always put our highest priority on conducting the most rigorous clinical and real world scientific research.

Our Scientific Research

Apollo Neuroscience is a company founded directly out of university science and research. We always lead with the scientific method, ask hard questions, and leave no stone unturned, all guided by world-renowned expert physicians and researchers. We are committed to only the most evidence-based scientific approaches to developing Apollo Neuro into a useful tool that improves our health and overall well-being.

The Five Science Principles of Apollo Neuro

  • All studies are conducted by independent university investigators and researchers that have no financial relationship with Apollo Neuroscience unless clearly stated otherwise.
  • All studies are independently funded (not funded by Apollo Neuroscience) unless clearly stated otherwise. To minimize bias as much as possible, nearly all studies of the Apollo technology are investigator-sponsored and are funded by government and university research grants. Investigators do not have a conflict of interest and receive no compensation in any form from Apollo Neuroscience.
  • Unlike other companies, we will never restrict the publication of trial results. Every investigator is free to publish what they find in their studies. Every completed clinical trial of the Apollo Neuro technology is available to the public.
  • We partner with world-renowned physicians and scientists to guide the Apollo Clinical Research Team to the highest standard of quality and rigor.
  • We hold ourselves to the best practices of the more current scientific methodology. For example, Apollo Neuroscience is one of the only consumer wellness wearables showing statistically significant (p<0.05) positive results in double-blind randomized placebo-controlled crossover trials, the most rigorous form of clinical trials.

We are proud to announce that two of our studies are double-blind randomized placebo-controlled crossover trials. It鈥檚 a bit of a mouthful to say, and even harder to actually pull off. We care deeply about the rigor of our research, so we鈥檙e excited to share what this means to us as a science-backed company.

What is a double-blind randomized placebo controlled crossover trial?

A double-blind randomized placebo-controlled trial (DBRPCT) is the gold-standard in scientific methodology for studying the impact of a therapy (technology or drug). These studies are accepted as producing results that are untainted by bias.

In a crossover trial, each study subject experiences all experimental conditions, so this dramatically increases the power and statistical validity of the results over a standard DBRPCT because each subject can serve as their own comparison. In a standard between-group DBRPCT, each subject who experiences Apollo vibrations would be compared to a different subject who experiences placebo. They are not the same person. In a crossover trial, each subject who experiences Apollo vibrations can be compared to their own results from experiencing every other experimental condition (including placebo) as well as to everyone else in the study. Running crossover trials makes the results gathered from clinical trials that much more useful by gathering much more data from each study subject.

Let鈥檚 do a quick breakdown of each element of this type of study.

Double-Blind:

Both subjects and researchers do not know which experimental condition (placebo or active intervention) the subjects are experiencing at any time during the running of the study.

Randomized:

A computer randomly assigns the experimental condition (vibration pattern or placebo) to each subject so the researchers don鈥檛 know what condition the subjects are in while they are running the study to prevent bias.

Placebo-Controlled:

There is at least one experimental condition whereby subjects experience what they believe to be the active intervention being tested, but it is a control condition meant to account for the effect of belief on study outcomes.

Crossover Trial:

Crossover trials are generally considered to be more powerful than typical between-group trials as each subject serves as their own control, reducing within-subject variability and increasing the sensitivity of the study. In a double-blind, randomized placebo-controlled crossover trial, such as those described here, subjects are exposed to every trial condition multiple times.聽

    Each study subject experiences all experimental conditions, which dramatically increases the power and validity of the results because each subject can serve as their own comparison. In a non-crossover clinical trial, each subject who experiences Apollo vibrations would be compared to another subject who experiences placebo. They are not the same person. In a crossover trial, each subject who experiences Apollo vibrations can be compared to their own results from experiencing every other experimental condition (including placebo) as well as to everyone else in the study. Running crossover trials often makes the results gathered from clinical trials that much more useful to us and allows us to get much more data from each subject.

    馃帠锔廜ur double-blind randomized placebo controlled crossover trials:

    Let鈥檚 do some math.

    In the newest double-blind randomized placebo-controlled crossover trial looking at Apollo鈥檚 impact on heart rate variability (HRV), there were 22 subjects.

    There were four conditions:

    • Pedal condition
    • Recovery condition
    • No-vibration condition
    • Calming vibration condition

    The sample size in this crossover trial with four conditions is 22 participants, and it has a similar statistical power as a between-group trial with four conditions and a total sample size of approximately 106 participants, assuming all other factors are equal (power, significance level, and number of conditions).

    • Sample sizes were estimated using G*Power for F tests <citation: Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191.>

    In the original double-blind randomized placebo-controlled crossover trial to understand Apollo鈥檚 effect on cognitive performance and HRV, there were 38 subjects and six conditions to be tested.

    There were six conditions (four placebo conditions compared to two active Apollo vibration conditions where all subjects experiences each condition twice):

    • Two active control vibration conditions (placebo one and two)
    • Two no vibration conditions (placebo three and four)
    • Two Apollo vibration conditions

    Each of the 38 subjects was exposed to all six of the conditions. Under this study methodology, this study has the equivalent of 212 subjects according to G*Power.

    • Sample sizes were estimated using G*Power for F tests <citation: Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191.>

    Meet the Scientific Advisory Board

    These leading experts oversee and support the rigor of the research behind Apollo Neuro.

    Headshot of Michael Breus, PhD

    Michael Breus, PhD

    The Sleep Doctor; Double board-certified Clinical Psychologist and Clinical Sleep Specialist; Diplomate of the American Board of Sleep Medicine

    Headshot of Rachel Yehuda, PhD

    Rachel Yehuda, PhD

    Vice Chair of Psychiatry, Endowed Professor of Psychiatry and the Neurobiology of Trauma, and Director of the Center for Psychedelic Psychotherapy and Trauma Research, Icahn School of Medicine, Mount Sinai; Director of Mental Health and PTSD Programming, Department of Veterans Affairs

    Headshot of Dr. Nicole Beurkens PhD

    Dr. Nicole Beurkens, PhD

    Licensed Clinical Psychologist, Board Certified Nutritionist specializing in evaluation and treatment of children with serious developmental and mental health conditions

    Headshot of Ronald D. Siegel, MD

    Ronald D. Siegel, PsyD

    Assistant Professor of Psychology, Harvard Medical School

    Headshot of Belinda Tan MD, PhD

    Belinda Tan MD, PhD

    Assistant Clinical Professor of Medicine, Harbor-UCLA Medical Center; Co-Founder of Science 37, a market leader in virtual clinical trials; Co-Founder and Co-CEO of People Science

    Headshot of Joseph C. Maroon, MD, FACS

    Joseph C. Maroon, MD, FACS

    Clinical Professor, Vice Chairman of Neurosurgery, University of Pittsburgh Medical Center; Heindl Scholar in Neuroscience; Team Neurosurgeon for the Pittsburgh Steelers

    Headshot of Dr. Ben Kelmendi

    Ben Kelmendi, MD

    Assistant Professor, Department of Psychiatry, Yale University; Co-Director, Yale Program for Psychedelic Science; Co-Founder, Yale Psychedelic Science Group

    Headshot of Bryan Donohue, MD, FACC

    Bryan Donohue, MD, FACC

    Interventional Cardiologist, Former Chair of Medicine & Chief of Cardiology, University of Pittsburgh Medical Center