News /
min read /
February 3, 2024

First-of-its-Kind Study Demonstrates Digital Therapeutic Significantly Improves Sleep and Mental Health for Stroke Patients


Evaluation shows the value of incorporating Big Health’s Sleepio, a clinically based digital therapeutic for insomnia, into the stroke rehabilitation process

SAN FRANCISCO, May 4, 2022Big Health, a digital therapeutics company dedicated to helping millions back to good mental health, participated in a new, first-of-its-kind study in collaboration with the University of Oxford evaluating how a digital therapeutic for insomnia can benefit stroke patients with self-reported sleep issues. Preliminary outcomes found more than 48% of participants who utilized Sleepio¹ – Big Health’s digital therapeutic for insomnia – experienced clinical improvement in sleep during post-stroke rehabilitation. In addition, the study found Sleepio users experienced less depression and anxiety 8-weeks post intervention. The study findings will be presented on May 4-6 at the European Stroke Organisation (ESO) conference being held in Lyon, France.

Stroke is frequently accompanied by sleep disruption, which persists throughout the long-term recovery process. A 2019 study noted approximately half of stroke survivors have insomnia, which is associated with higher rates of incident stroke and worse post-stroke outcomes. Sleep is critical for post-stroke recovery, as research has shown quality sleep supports the brain’s ability to re-learn muscle movements, regain strength, and improve motor functions.

“We are proud to collaborate with Big Health on this innovative study, which shows Sleepio, an online cognitive behavioral therapy program, is effective at improving sleep condition and mood in chronic stroke survivors,” said Melanie K. Fleming, research fellow in the Nuffield Department of Clinical Neurosciences at the University of Oxford and lead author of the study. “Cognitive behavioral therapy is a recommended treatment for sleep problems and based on preliminary outcomes, should be considered as part of the multidisciplinary care pathway after stroke. This study indicates the ability for digital therapeutics to effectively expand access to cognitive behavioral therapy and improve health outcomes for people with comorbid health conditions.”

According to leading treatment guidelines, including the National Institute for Health and Care Excellence (NICE), cognitive behavioral therapy (CBT) is recommended as the first line treatment for insomnia. Expanding access of CBT to patients who have experienced stroke can serve as an effective treatment to improve sleep conditions and support recovery.

Sleepio is a digital sleep-improvement program which takes evidence-based non-drug therapies, including cognitive behavioral therapy, and fully automates them, enabling patients to access proven treatment for insomnia without needing to see a physician. In a clinical trial, Sleepio helped 76% of people achieve clinical improvement in insomnia.

“Good quality sleep is a critical component for recovery among stroke patients,” said Colin Espie, Ph.D., co-founder and chief scientist of Big Health and professor of sleep medicine in the Nuffield Department of Clinical Neurosciences at the University of Oxford. “Poor sleep can slow recovery and lead to other conditions, including affecting memory and an increased risk of depression. These preliminary outcomes evaluated in collaboration with the University of Oxford provide a new approach to how we can support stroke patients throughout rehabilitation whose quality of sleep is critical for successful recovery.”

A secondary analysis with secondary measures and follow-up assessments are to be evaluated and published for full clinical publication. Research reported in this press release was supported by Wellcome Trust.

About Big Health

Big Health’s mission is to help millions back to good mental health by providing safe and effective non-drug alternatives for the most common mental health conditions including insomnia and anxiety. Designed by leading clinical experts, Big Health’s digital therapeutics expand access to gold standard care, including behavioral medicine, and are backed by industry-leading research and randomized controlled trials. By seamlessly integrating across the care pathway, from member engagement to billing via pharmacy benefit managers, Big Health simplifies adoption for both payers and patients, providing an inclusive, scalable, and affordable approach without serious side effects. For more information, please visit or follow Big Health on LinkedIn and Twitter.

For media inquiries, please contact

¹ In accordance with FDA’s Current Enforcement Discretion Policy for Digital Health Devices for Psychiatric Disorders, for patients aged 18 years and older, who are followed by and diagnosed with Insomnia Disorder or Generalized Anxiety Disorder by a medical provider, Sleepio and Daylight can be made available as an adjunct to their usual medical care for Insomnia Disorder or Generalized Anxiety Disorder, respectively. Sleepio and Daylight do not replace the care of a medical provider or the patient’s medication. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for these indications.

During the COVID-19 public health emergency, Sleepio and Daylight are being made available as treatments for insomnia disorder and generalized anxiety disorder (GAD), respectively, without a prescription. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia disorder and GAD, respectively.

1. Qaseem, A., Kansagara, D., Forciea, M. A., Cooke, M., & Denberg, T. D. (2016). Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 165(2), 125-133.2. Riemann, D., Baglioni, C., Bassetti, C., Bjorvatn, B., Dolenc Groselj, L., Ellis, J. G., … & Spiegelhalder, K. (2017). European guideline for the diagnosis and treatment of insomnia. Journal of Sleep Research, 26(6), 675-700.3. Wilson, S., Anderson, K., Baldwin, D., Dijk, D. J., Espie, A., Espie, C., … & Sharpley, A. (2019). British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update. Journal of Psychopharmacology, 33(8), 923-947.4. King’s Technology Evaluation Centre. (2017, November 9). Overview: Health app: SLEEPIO for adults with poor Sleep: Advice. NICE. Espie, C. A., Kyle, S. D., Williams, C., Ong, J. C., Douglas, N. J., Hames, P., & Brown, J. S. (2012). A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep, 35(6), 769-781.6. Carl, J. R., Miller, C. B., Henry, A. L., Davis, M. L., Stott, R., Smits, J. A., … & Espie, C. A. (2020). Efficacy of digital cognitive behavioral therapy for moderate‐to‐severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depression and Anxiety, 37(12), 1168-1178.

DOC-3046 Effective 11/2023