New research reveals that Sleepio, a digital cognitive behavioral therapeutic for insomnia by Big Health, reduces anxiety symptoms in individuals with co-existing insomnia and anxiety, while a separate study highlights the treatment’s impact on stroke survivors. 

The findings advance clinical evidence demonstrating that Sleepio is a safe and effective, non-drug alternative to treating global, co-occurring conditions, according to a release from Big Health.

Key findings from the two peer-reviewed 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. Additionally, comorbid insomnia and anxiety are associated with greater severity of both conditions—as well as increased symptoms of depression and poorer physical health.

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. 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 psychology at the University of Oxford and co-author of the paper, says in a release. “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, according to the World Stroke Organization. Following stroke, up to 60% of patients report sleep challenges throughout the recovery period. Sleep issues are associated with poorer post-stroke outcomes, and higher rates of comorbidity, including anxiety and depression.

The Journal of Sleep Research published results from the INSPIRES study, a randomized controlled trial 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, says in a release. “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, says in a release. “Most importantly, these findings also advance the significant evidential foundation proving the benefits of digitally-delivered cognitive behavioral therapies.”

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