Pear Therapeutics highlighted data today from two studies of a digital cognitive behavioral therapy that acted as the precursor for Somryst, the prescription digital therapeutic for adults with chronic insomnia that was the first to pass through the FDA's Pre-Cert pilot pathway.
The first, a randomized controlled trial of 1,149 Australian adults with insomnia and depressive symptoms, suggested that nine weeks with the treatment could drive better sleep outcomes.
The second reviewed the user journeys of 151 patients who dropped out of a prior randomized controlled trial conducted using the early version of Somryst to determine predictors of intervention dropout.
Both studies were led by clinical researchers from Pear Therapeutics, with the first reporting direct funding from the company. Each writeup was published as an online poster presentation for Virtual SLEEP 2020, an annual meeting of the Associated Professional Sleep Societies.
Compared to controls, randomized controlled trial participants given the treatment demonstrated significant gains from baseline in sleep-onset latency (p < .0001), wake after sleep onset (p < .0001), the number of times they woke up ( p = .0113), sleep efficiency ( p < .0001) and sleep quality (p < .0001). Total sleep time improved significantly at the 12-month (p = .0013) and 18-month (p = .0015). follow ups, but not immediately after use or at six months. These data were primarily collected via online participant sleep diaries.
In the user journey review, researchers identified a handful of predictors for treatment dropout among those given an early form of the digital treatment. These included the length of time it took patients to complete a treatment core, the volume of email support messages and time to get out of bed once awake at baseline. With these factors, the researchers said they created a predictive decision tree that achieved area under curve values ranging between 0.6-0.9.
WHY IT MATTERS
The larger analysis of the Somryst precursor reinforces the modality's place as a scalable first-line treatment for chronic insomnia, regardless of coexisting symptoms of depression. However, the findings of the second trial puts the emphasis on a major strength of digital therapeutics: generation and collection of large volumes of individualized usage and adherence data.
These can be used to fine-tune Pear's treatments for greater adherence and effectiveness – or in some cases, an idea of when a digital therapeutic may not be the way to go for certain patients.
"[The data] will allow us to refine therapeutic content and interfaces to support continuing engagement with treatment.,” Dr. Yuri Maricich, chief medical officer at Pear Therapeutics and an author on one of the studies, said in a statement. “These studies provide additional evidence that [prescription digital therapeutics] can play a vital role in the treatment of people with chronic insomnia and break down the barriers to access guideline recommended first line treatment of care.”
THE LARGER TREND
Pear first announced that its chronic insomnia treatment would be the first to put the FDA's Pre-Cert pilot program through its paces in 2019, and eventually received that clearance in March of this year. Since then, the company launched a decentralized, open-label trial of the prescription digital therapeutic, and even rolled out its experimental schizophrenia therapeutic in a limited capacity during the COVID-19 crisis.
But Pear isn't alone in its data-driven approach to digital sleep-health treatments. Just a couple weeks ago, a Big Health-supported trial of the company's Sleepio product was published in the Journal of Sleep Research. This study similarly recruited users with sleep issues and depressive symptoms, and found that the digital program clinically improved markers of both conditions.