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The goal of the 40Winks study is to evaluate and improve methods of measuring sleep at home, which may help inform the development of diagnostics and treatments that are user-friendly, cost-effective, and reliable.

Man sleeping with smartwatch

How It Works

  • Participants will be provided a wearable wrist device (Fitbit) and a bed sensor (Withings) which will be placed under your mattress.
  • With your iPhone, you’ll download the study app and use it to complete a sleep diary.
  • Over the course of two weeks, you’ll track, monitor, and share your sleep data via these devices.
  • Participants will be compensated up to $150 for their time contributing to the study.
40Winks - Digital Health illustration
Digital health sleep dashboard

Why Participate

  • Your participation can help determine the best use of new technologies to measure sleep at home. These technologies may be used in the future to help improve the sleep of people suffering from brain disorders.
  • Using a sleep activity dashboard, you’ll gain a better understanding of your sleep patterns by tracking and reviewing your own sleep data.

Eligibility Overview

  • Healthy adult volunteers, or adults self-reporting insomnia
  • Willing to participate for two weeks
  • Male or female, 18-77 years of age, inclusive
  • Participants need a reliable connection to the internet and must be willing to use their own iPhone as prescribed

About the Study Sponsor

Cohen Veterans Bioscience is a non-profit 501(c)(3) biomedical research and technology organization dedicated to advancing brain health by fast-tracking precision diagnostics and tailored therapeutics.

Cohen Veterans Bioscience

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Learn More About Clinical Trial Participation Opportunities

There are many different ways to find out about clinical research opportunities that might be of interest to you. Many doctors offices have brochures or advertisements about studies they are conducting or someone in their practice or hospital are conducting. A local study site might advertise on the radio or on the internet about their study. The sponsor of a study may have a website dedicated to informing people about the study. These websites may allow you to see if there is a study site near you.

Many patient advocacy groups also list available clinical studies on their websites. And finally, as all clinical studies of new treatments are required to be listed on a national registry, you can also search for your area of interest and “recruiting” or “not yet recruiting” at ClinicalTrials.gov.

Cohen Veterans Bioscience has several studies that are ongoing or about to start that you may be interested in learning more about.

Get More Information

Interested in joining on of our studies or getting more information? Feel free to reach out to us today.

Contact Us

Suicide rates among Veterans are not improving.
We can and must do better.

Up to 22
Up to 22

Tragically up to 22 American Veterans and service members die by suicide daily.

300,000
300,000

Nearly 300,000 Veterans who returned from the wars in Iraq and Afghanistan are suffering from PTSD.

Veterans and service members need more treatment options.

Despite decades of promising research and more than $1.1 billion spent on clinical trials1, no new drugs for PTSD and TBI have successfully advanced to FDA approval. And the research pipeline for new devices and therapies is thin as many pharmaceutical companies have abandoned research into PTSD and TBI.

Complex problems require a new approach that embraces collaborative science conducted to the highest standards of quality and with an openness to share data towards a common goal.

About the Coalition

Co-founded by Cohen Veterans Bioscience, the Coalition to Heal Invisible Wounds brings together leading non-profit organizations seeking to advance a comprehensive research-focused advocacy agenda to address the invisible wounds of war—PTSD and TBI—as well as to address co-morbid conditions such as pain and substance use disorders, which are known to dramatically increase the risk of suicide among Veterans and service members.

Advocacy Priorities

The Coalition seeks to promote reforms, policies and meaningful research investments that will spur new research discoveries and advance a precision medicine approach for the invisible wounds of war.

Coalition Members

The ultimate goal of the Coalition’s advocacy efforts is to realize better treatments, improved quality of life, new cures, and a reduction in the rate of suicide among Veterans and service members.

Chair

Co-Chair

Contact

For more information about the Coalition to Heal Invisible Wounds and how to become a member, please contact our Senior Director of External Affairs, Dr. Chantelle Ferland-Beckham.

Dr. Chantelle Ferland-Beckham, Ph.D.
Senior Director, External Affairs
Contact via Email

Fostering a collaborative approach to advancing solutions for brain trauma

Galvanizing the brain health ecosystem

Program

Brain Health Nexus

The Brain Health Nexus initiative aims to unleash science and technology to build a new paradigm of collaboration to optimize brain health and prevent brain disease. In the current research landscape, each brain disease is addressed separately. But these diseases do not exist in isolation. We need coordinated action to broaden the focus from treating diseases at crisis points to prevention and wellness across the lifespan. It will take one interconnected community to break down barriers and borders, share data and insights, and bridge capital and opportunity.

Identifying biomarkers for brain disorders

Learn More About CVB

There are two main types of clinical research

  1. Observational studies, also called natural history studies, collect health information to understand how a disease progresses over time, or how someone without the disease might fare over a similar time period.

  2. Clinical studies or trials test new treatments (i.e., new drugs, surgical procedures, devices, behavioral treatments, or even the role of caregivers and support groups) for diseases or new ways to diagnose disease.

Who participates?

Every person who chooses to participate in clinical research does so for their own reasons. Some of the main reasons people participate are:

  • The treatments they have tried for their health problem did not work.
  • There is no treatment for their health problem, and, by being part of a clinical trial, they may learn about new treatments before they are widely available.
  • They prefer the comprehensive health care they may receive during the study.
  • While they are healthy, there may be a disease that is common in their family, and they want to help find ways to prevent it.
  • They feel participating offers a way to play an active role in their own health care.
  • They want to help researchers learn more about certain health problems.

Regardless of your reason and regardless of the outcome of the study, your participation helps move science forward. Without your participation we could not discover new treatments or find ways to better help future generations.

You can participate in clinical trials in different ways.

You can join a study directly and participate in real time or you can give permission to your health care provider to include your data or samples (blood or tissue) in their research.

While each study is different, there are strict regulations about how they should be conducted, and many of the steps are the same.

  1. A member of the study team will explain the trial to you in detail and they will give you information to read at home if you are not yet ready to make a decision about participating.
  2. The study team will ask you questions to better understand if you will be eligible for the study, e.g. are you the right age, do you have the time participate?
  3. You can ask the study team any questions you have and once you feel all of your questions are answered and you agree to participate, you will sign a form documenting what was explained to you about the study. This is called an informed consent and it also has information about who to contact if you have questions later or if you change your mind about participating, as well as information about how the study team is protecting your data privacy rights.
  4. You will then be screened to make sure you qualify for the trial.
  5. From here, the next step are determined by the study design.
  1. In your first visit, which may be in the clinic or at home, the researchers conduct tests to record a baseline of your health before you take any study treatment. These tests might include a physical exam, a memory test, doing a blood draw (e.g. for cholesterol levels), or having you fill out behavioral scales.
  2. You are randomly assigned to a group that receives the treatment being tested or to the control group.
  3. You follow the trial procedures, which might include repeating some of the tests done at the first visit, and report any issues or concerns to researchers.
  4. The study team, who does not know which group you are in, keeps detailed records of how your health has changed, if at all, as well as any side effects you report.
  5. Regardless of the study type you participate in, you will continue to see your regular physician for usual health care throughout the study.

Clinical Trial Participation Opportunities

There are many different ways to find out about clinical research opportunities that might be of interest to you. Many doctors offices have brochures or advertisements about studies they are conducting or someone in their practice or hospital are conducting. A local study site might advertise on the radio or on the internet about their study. The sponsor of a study may have a website dedicated to informing people about the study. These websites may allow you to see if there is a study site near you.

Many patient advocacy groups also list available clinical studies on their websites. And finally, as all clinical studies of new treatments are required to be listed on a national registry, you can also search for your area of interest and “recruiting” or “not yet recruiting” at ClinicalTrials.gov.

Cohen Veterans Bioscience has several studies that are ongoing or about to start that you may be interested in learning more about.

Get More Information

Interested in joining on of our studies or getting more information? Feel free to reach out to us today.

Contact Us

Establishing universal standards for data collection

PTSD Therapeutic Area User Guide v1.0

In partnership with the Clinical Data Interchange Standards Consortium (CDISC), we published the first Therapeutic Area (TA) Standard for PTSD. The guide describes how data should be recorded in a standardized database, establishing best practices across the clinical research industry for recording, reporting, and sharing disease-specific data. Using the guide can facilitate regulatory submissions for novel therapies and allow the research community to easily compare data from different studies. This guide is critical for the future of data integration and collaboration that can accelerate the discovery of better diagnostics and treatment options for PTSD.

We hope researchers will use this user guide to bring clarity to the data and discover breakthroughs in PTSD.

– David R. Bobbitt
President and CEO, CDISC

Preclinical Common Data Elements for Traumatic Brain Injury

Big data approaches are critical to accelerating discovery in complex disorders such as traumatic brain injury (TBI). Common data elements (or CDEs) enable big data approaches by providing consistency in the way data is collected, formatted and described from one study to the next. Members of the Cohen Veterans Science scientific team were part of a committee of experts who worked with the National Institute of Neurological Disorders and Stroke to spearhead the development of CDEs for preclinical TBI research.

Enhancing the quality of preclinical data

Global Preclinical Data Forum

The Global Preclinical Data Forum (GPDF) is a jointly sponsored U.S. and European initiative that encourages global collaboration to address the challenge of ensuring that preclinical research is reproducible, robust, and translatable. The GPDF provides training, education, and other resources that address modern issues in preclinical research with the goal of systematically advancing best practices that will enhance the quality of the preclinical data for clinical research and development. Cohen Veterans Bioscience is the fiscal sponsor of the GPDF and part of the GPDF leadership Core Team.

PEERS: The Platform for The Exchange of Experimental Research Standards

Laboratory assays and tests have become increasingly diverse and complex. Confronted with a multitude of information with unclear relevance for their specific experiments, scientists run the risk of overlooking critical factors that can influence the outcome of their studies. PEERS is a community-driven, open access database that will improve the reproducibility of preclinical studies by providing scientists with an expertly curated catalogue of the major factors that can influence the outcome of an experiment when not considered a priori.

Sex as a Biological Variable Video Training Series

Differences between males and females extend far beyond reproduction, with significant implications for human health and disease. This is particularly relevant in neuroscience, where difference in basic biology between males and females translates into sex differences in the prevalence, progression, and responses to treatment of many brain disorders. Cohen Veterans Bioscience developed an unprecedented new video series that provides the practical knowledge necessary for preclinical researchers to incorporate sex as a biological variable into their current and future research. The 18-part video training program was developed to help strengthen the translation of basic research findings to human care and enhance the overall quality of preclinical research.

EQIPD

There are no universally agreed upon guidelines that govern the design, conduct, and analysis of preclinical research. As a result, the development of new medications has slowed dramatically in the last 10 years due to the high risk of failure. The EQIPD project (2017-2021) aimed to reverse this trend by bringing together a consortium of over 20 research groups from industry and academia to develop a simple, strategies to reduce the risks of drug development research and ensure adherence to rigorous research practices. The Guarantors of EQIPD were founded in 2021 to disseminate the developed strategies to the research community. Cohen Veterans Bioscience is a fiscal sponsor of the Guarantors of EQIPD.

Incentivizing the publication of negative data

When science is properly conducted, negative results, or results that do not confirm the expected outcome or original hypotheses, are a natural occurrence. However, much of the science that is published is skewed towards positive results, with some estimates indicating that 85% of all published studies in neuroscience publish only positive results. The end result is a loss of time and money as researchers pursue avenues of scientific inquiry that are bound to fail. Cohen Veterans Bioscience believes that we need a paradigm shift in which negative data is valued according to the same standards as positive data and has taken a number of steps to demonstrate the value of negative data to the scientific process.

Best Negative Data Prize in Preclinical Neuroscience

  • Learn more and see the list of past prize winners here.

Best Negative Data Prize in Clinical Neuroscience

  • Learn more here.
  • See the publications from the past winner here

Neurotrauma Reports Null Hypothesis Section

  • Learn more here.
  • Read the publications here.
  • Q&A with one of the authors in the collection can be found here.

Discovering critical biomarkers to help match PTSD patients to the most effective treatment

The Biomarker Establishment for Superior Treatment of PTSD Study (BEST)

In partnership with our research collaborators at Stanford University, we studied clinical biomarkers to identify brain activity patterns, or neural signatures, in PTSD within a large Veteran population.

The results showed that PTSD patients could be stratified into groups based on changes in blood flow in a brain circuit, showing a correlation with patients who responded to prolonged exposure psychotherapy, a common PTSD treatment. These findings help move PTSD diagnosis and treatment away from a symptoms-based approach to a biologically-based approach, which can provide the basis for the development of targeted treatments and novel therapeutics.

Our goal is to create a brain signature specific to an individual and then tailor treatment accordingly. Ultimately, we hope to have a clinic-ready tool that will dramatically change how we care for patients with post-traumatic stress disorder.

– Amit Etkin, MD, PhD
Professor of Psychiatry and Behavioral Sciences, Stanford University

Discovering the genetic risk of PTSD

The Global PTSD Genetics Study

Through coordination with more than 200 researchers, across 12 countries, researching genetic data from more than 200,000 people, we demonstrated that the risk of developing PTSD after experiencing trauma is heritable. The study advanced our understanding of PTSD, demonstrating that heritability estimates for PTSD range between 5-20%, which are similar to rates observed for major depression.

We need a drug discovery revolution in PTSD…unbiased genetics approaches will provide the basis for new, rational therapeutics – and may eventually help us better match treatments to patients.

– Karestan C. Koenen PhD
Principal investigator, Stanley Center for Psychiatric Research, Broad Institute and Harvard T.H. Chan School of Public Health

Improving the diagnosis of traumatic brain injury (TBI)

Normative Neuroimaging Library (NNL)

Advanced MRI imaging can now detect microscopic changes in brain structure and/or function caused by trauma or disease. By performing standardized MRI scans on 3,000 adult volunteers who have not been affected by brain trauma or disease, we are forming a library that documents normal population variation. This imaging library would allow physicians to accurately and efficiently diagnose conditions resulting from subtle and early changes in brain structure.

The TBI imaging reference library will provide key information necessary to capitalize on these increasingly available analytical approaches to allow for imaging to help support decisions in the management.

– James R. Stone, MD, PhD
NNL principal investigator, and Vice Chair of Research, UVA Department of Radiology and Medical Imaging

Developing digital health solutions for insomnia

Sleepwell

Sleep disruptions are one of the most debilitating symptoms of PTSD and TBI, and are a risk factor for suicide. We’re developing digital health solutions to validate and analyze data collected from wearables that capture the minute-to-minute experiences of people whose lives are disrupted by PTSD and other brain disorders. Improving methods of measuring sleep will enable the development of precision therapeutics for sleep disorders that are user-friendly, cost-effective, and reliable.

Tracking disease progression in early stage Parkinson’s disease

Parkinson’s Progression Markers Initiative (PPMI) Data Science Modeling Group

The Parkinson’s Progression Markers Initiative (PPMI), sponsored by The Michael J. Fox Foundation (MJFF), is a landmark clinical study designed to identify biomarkers of Parkinson’s disease to predict disease progression and improve patient care. In our aligned missions to advance brain health, MJFF is partnering with CVB’s data science team to quantitatively explore, evaluate, and predict disease trajectory and risk factors using the collected data. The goal of the PPMI is to support the development of new therapies for use in clinical trials.

Technical Performance Verification Study

Sleep disturbance is common in individuals with post-traumatic stress disorder (PTSD). The gold standard assessment for sleep disruptions is the overnight polysomnogram (PSG), which are cumbersome, have a high cost, and not always reflective of how you sleep in your own home. With the growing availability of wearable and home sensor devices that can measure your sleep CVB conducted a study to compare the accuracy of these devices to PSG in people with insomnia and PTSD and (2) understand what each device is measuring and how equivalent their sleep reporting across devices.

Based on rigorous testing in our EarlySignal device lab, we selected the most promising six devices and launched a Technical Performance Verification study with our partners, a leading sleep research team at the University of Pennsylvania. Participants in the study, those with both insomnia and PTSD, spent two nights in the sleep lab wearing the PSG and the six devices in order to help us learn which of these potential sleep devices is the most accurate against the gold standard.

The study completed enrollment in 2022 and results will be updated here and published soon thereafter.

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Advocacy Priorities

Our brain trauma roadmapping efforts in both post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) have demonstrated that meaningful investment in brain health is needed to advance diagnostics and treatments.

CVB advocates for sustainable and predictable growth of the NIH budget over the long term, including targeted funding for brain trauma-related disorders in an amount that is commensurate with the actual disease burden and reflects priority areas identified in our roadmapping efforts. We also support robust and continued funding for the BRAIN Initiative and a call-to-action that all data from the BRAIN Initiative be made openly accessible to the scientific community to advance progress.

Current treatment strategies for many brain diseases and disorders largely resemble “trial and error” and many diseases rely on a symptoms-based approach to diagnosis and treatment. In brain health, doctors need better tools to tailor treatments to the right patient and the right condition.

We support Federal funding that moves beyond an incremental approach to brain science, including funding deep phenotype cohorts to enable biomarker discovery, adaptive clinical trial designs and promoting data sharing to enhance discovery and development.

Accelerating research discovery—particularly in the field of brain health—requires researchers to build upon the best available scientific evidence in order to avoid needless starts and stops and duplicated efforts.

For these reasons, CVB advocates for policies that ensure best research practices based on proven approaches, which are implemented at all stages of the research process—from design to execution to reporting.

Through the implementation of best practices, we ensure all research is conducted to the highest standards and through an approach that ensures public confidence. In addition, CVB advocates for improved biomedical workforce training at all levels to protect the United States’ competitiveness as a scientific enterprise.

Our nation’s Veterans and service members need action for the brain trauma conditions that are taking their lives at record numbers — TBI and PTSD — collectively referred to as the invisible wounds of war.

Major federal investments have improved access to mental health care, but Veterans and service members need more treatment options.

Despite decades of promising research and more than $1.1 billion spent on clinical trials, no new drugs for PTSD and TBI have successfully advanced through clinical trials to achieve FDA approval. And the research pipeline for new devices and therapies is thin as many pharmaceutical companies long ago abandoned research into PTSD and TBI.

CVB advocates for policies and reforms to help close these research gaps to more effectively address the invisible wounds and bring new solutions for brain trauma to Veterans and service members.

Veterans Advisory Council

The Veterans Advisory Council (VAC) is comprised of senior leaders who have a deep, personal commitment to helping us discover new solutions for the invisible wounds of war. The VAC members share the perspectives, challenges, and needs of the Veterans community to inform CVB’s research and advocacy efforts that will help improve the health of Veterans. The VAC’s priorities are to increase awareness of brain trauma as a risk factor for suicide, reinforce legislation and other measures to advance evidence-driven approaches for the invisible wounds of war and serve as a voice by providing advice and strategic recommendations for CVB’s mission and objectives.

Coalition to Heal Invisible Wounds

Co-founded by Cohen Veterans Bioscience, the Coalition to Heal Invisible Wounds brings together leading non-profit organizations seeking to advance a comprehensive research-focused advocacy agenda to address the invisible wounds of war—PTSD and TBI—as well as to address co-morbid conditions such as pain and substance use disorders, which are known to dramatically increase the risk of suicide among Veterans and service members.

News and Events

Have Questions? Interested in Learning More?

Contact our Director of Advocacy and Policy to learn more about how you can become involved with our advocacy efforts.

Dr. Chantelle Ferland-Beckham, Ph.D.
Senior Director, External Affairs
Contact via Email

The Cohen Veterans Care Summits held in 2016, 2017, and 2018 explored the future of brain health care and advanced the field through collaborative sessions featuring top leaders.

The Summits were jointly hosted by Cohen Veterans Bioscience and Cohen Veterans Network, both leading national non-profit organizations funded by financier-philanthropist Steven A. Cohen to advance post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) care.

Frank Larkin Discusses Suicide Prevention

Hear from Frank Larkin as a guest speaker at the 2017 Cohen Veterans Care Summit.

Watch Now