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February 3, 2024

New Research Demonstrates Clinical Effectiveness of Digital Treatment at Improving Insomnia and Comorbid Mental and Physical Health Issues


Findings advance the clinical evidence foundation demonstrating that Sleepio, a digital cognitive behavioral therapeutic for insomnia, is a safe and effective, non-drug alternative to treating global, co-occurring conditions

SAN FRANCISCO and OXFORD, UK, October 9, 2023 — Big Health, the leader in digital therapeutics for the most common mental health conditions, announced today the publication of two, peer-reviewed studies demonstrating the effects of its flagship digital insomnia treatment Sleepio in individuals with co-morbid insomnia and clinically significant anxiety as well as in stroke survivors.

Digital cognitive behavioral therapy (dCBT) has long been evidenced as an effective treatment for insomnia and anxiety — key findings from these studies provide new insights into Sleepio’s impact. Topline results include:

  • Eighty-four percent of improvements in anxiety among study participants using Sleepio were due to improvements in sleep.
  • In a separate study among stroke survivors, 71% achieved remission using Sleepio compared to 30% of control participants.

Improving sleep is a pathway to reduce anxiety

Individuals with insomnia are three times more likely to develop anxiety than healthy sleepers.1 Additionally, comorbid insomnia and anxiety are associated with greater severity of both conditions — as well as increased symptoms of depression and poorer physical health.2

Published in the peer-reviewed Journal of Affective Disorders, researchers found that Sleepio’s clinically validated impact on insomnia also significantly reduced participants’ anxiety symptoms — 84% of improvements in anxiety were due to improvements in sleep. The largest-ever study examining the effects of a digital therapeutic for insomnia in adults with insomnia and clinically significant anxiety, results also showed that after using Sleepio, participants were two times more likely to no longer have clinically significant anxiety versus those in the control arm.

“The results of our studies show that digital CBT for insomnia can bring about substantial improvements in sleep, and that leads to a lessening of anxiety and depression,” Daniel Freeman, PhD, Professor of Professor of Psychology at the University of Oxford and co-author of the paper, said. “Improving sleep likely brings a wide range of benefits in its wake.”

The impact of sleep on stroke recovery

Globally, one in four people are estimated to experience stroke during their lifetime, and the disease is the third leading cause of disability and death combined.3 Following stroke, up to 60% of patients report sleep challenges throughout the recovery period.4 Sleep issues are associated with poorer post-stroke outcomes and higher rates of comorbidity,5 including anxiety and depression.6

The peer-reviewed Journal of Sleep Research published results from the INSPIRES study, a randomized controlled trial (RCT) comprising 84 stroke survivors demonstrating that Sleepio was effective at improving sleep, compared with sleep hygiene control, for at least eight weeks post-intervention. Results also showed that, among participants who had insomnia disorder at baseline, 71% in the Sleepio study arm achieved remission post-intervention compared to 30% of control participants. In addition, Sleepio participants reported taking less time to fall asleep and had greater improvements in mood compared with control.

“Given the critical role sleep plays in motor learning and cognitive functioning, and the impact sleep difficulties can have on stroke outcomes, it is promising to see that digital therapeutics, such as Sleepio, can improve sleep meaningfully in this population,” Melanie K. Fleming, PhD, research fellow, Nuffield Department of Clinical Neurosciences at the University of Oxford and lead researcher of the study, said. “These data, in combination with the vital role sleep plays in brain health, underscore the clinical need to treat sleep disturbances and insomnia in stroke survivors.”

The foundation of clinical evidence behind digital CBT

These recently published studies build upon data presented earlier this year at both SLEEP 2023 and ASCO 2023, which demonstrated meaningful improvements of Sleepio use in patients with cancer, cancer-induced menopause and adults aged 65 and older.

“These new data highlight how treating sleep issues has mutually-reinforcing health benefits across disparate populations, conditions, and ages — getting consistent rest is critical to healing our bodies and brains, and essential to cultivating a healthy mind,” Colin A. Espie, PhD, Professor of Sleep Medicine, University of Oxford and co-founder and Chief Scientific Officer of Big Health, said. “Most importantly, these findings also advance the significant evidential foundation proving the benefits of digitally-delivered cognitive behavioral therapies.”

About the Journal of Affective Disorders study

Led by researchers at Big Health and the University of Oxford, this study was a controlled sub-analysis combining individual participant data from two previous RCTs of Sleepio. In the original RCTs, participants received either Sleepio or control (usual care or sleep hygiene education). In the current study, data were included from 2,172 participants with insomnia disorder and clinically significant anxiety symptoms (defined as having a Generalized Anxiety Disorder scale (GAD-7)  score of ≥10 at baseline), and outcomes were examined at post-intervention (weeks 8 or 10), and follow-up (weeks 22 or 24). The effects of Sleepio on insomnia and anxiety symptoms were examined, and mediation analyses assessed whether improvements in sleep at post-intervention explained the benefits to anxiety at follow-up.

About the INSPIRES trial

The INSPIRES trial was a two-arm parallel RCT examining the effectiveness of Sleepio at improving sleep, compared with sleep hygiene education in 84 stroke survivors. The primary endpoint was insomnia symptoms, assessed using the eight-item Sleep Condition Indicator (SCI-8) at post-intervention. A follow-up assessment was conducted eight weeks later. Secondary outcomes included sleep diary variables, actigraphy, depressive symptoms, anxiety symptoms, self-efficacy, quality of life, and stroke impact.

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 X.

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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.

DOC-3374 Effective 10/2023


  1. Hertenstein E, Feige B, Gmeiner T, Kienzler C, Spiegelhalder K, Johann A, Jansson-Fröjmark M, Palagini L, Rücker G, Riemann D, Baglioni C. Insomnia as a predictor of mental disorders: a systematic review and meta-analysis. Sleep medicine reviews. 2019 Feb 1;43:96-105.
  2. Madeleine Blank, Jihui Zhang, Femke Lamers, Adrienne D. Taylor, Ian B. Hickie, Kathleen R. Merikangas, Health Correlates of Insomnia Symptoms and Comorbid Mental Disorders in a Nationally Representative Sample of US Adolescents, Sleep, Volume 38, Issue 2, 1 February 2015, Pages 197–204,
  3. Feigin VL, Brainin M, Norrving B, Martins S, Sacco RL, Hacke W, Fisher M, Pandian J, Lindsay P. World Stroke Organization (WSO): global stroke fact sheet 2022. International Journal of Stroke. 2022 Jan;17(1):18-29.
  4. Kim WH, Jung HY, Choi HY, Park CH, Kim ES, Lee SJ, Ko SH, Kim SY, Joa KL. The associations between insomnia and health-related quality of life in rehabilitation units at 1 month after stroke. J Psychosom Res. 2017 May;96:10-14. doi:10.1016/j.jpsychores.2017.02.008. Epub 2017 Feb 21. PMID: 28545786.
  5. Fleming MK, Smejka T, Henderson Slater D, van Gils V, Garratt E, Yilmaz Kara E, Johansen-Berg H. Sleep Disruption After Brain Injury Is Associated With Worse Motor Outcomes and Slower Functional Recovery. Neurorehabil Neural Repair. 2020 Jul;34(7):661-671. doi: 10.1177/1545968320929669. Epub 2020 Jun 7. PMID: 32508249; PMCID: PMC7327954.
  6. Glozier N, Moullaali TJ, Sivertsen B, Kim D, Mead G, Jan S, Li Q, Hackett ML. The course and impact of poststroke insomnia in stroke survivors aged 18 to 65 years: results from the Psychosocial Outcomes In StrokE (POISE) Study. Cerebrovascular diseases extra. 2017 Feb 3;7(1):9-20.

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