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Trial Underway Assessing Insomnia Therapy App

Insomnia

(Alyssa Miller, Flickr)

13 July 2020. A clinical trial began enrolling participants to collect real world evidence on a digital therapy designed to relieve chronic insomnia. The study, called a decentralized clinical trial since all data are collected remotely, is conducted by Pear Therapeutics Inc. in Boston and San Francisco, developer of Somryst, the digital insomnia treatment being evaluated.

Insomnia is a common disorder marked by interrupted sleep, which can last for days at a time. When the condition lasts for a month or more, it’s considered chronic insomnia and may be the result of underlying stress that requires more intensive and professional interventions. The company says some 30 million people in the U.S. experience chronic insomnia.

Pear Therapeutics develops what it calls prescription digital therapeutics that harness capabilities of electronic technologies to treat disease. The company says that even in digital form, its therapies are designed to treat serious disorders, evaluated with human clinical trials, subject to FDA review, and require a prescription. Pear Therapeutics designed its Somryst software as part of a personalized cognitive behavioral therapy program, administered by a clinician, for chronic insomnia. As reported by Science & Enterprise in March, the Food and Drug Administration cleared Somryst for marketing in the U.S.

Cognitive behavioral therapy is a form of psychotherapy that seeks to change attitudes and behavior by concentrating on a person’s cognitive processes — thoughts, images, and beliefs — related to that individual’s behavior. And while this therapy is considered a first line treatment for insomnia, the number of clinicians trained in its use are limited.

Somryst, says Pear, sets specific times for going to bed and waking, called a sleep window, then identifies behavior by the individual to change to achieve that sleep window goal. The software also helps the individual learn to identify and shift thought patterns that contribute to sleeplessness. In addition, Somryst helps identify lifestyle and environmental changes to achieve better sleep, and provides guidance for the future, including handling a relapse.

While FDA already cleared Somryst for marketing in the U.S., Pear Therapeutics is asking users to document real-world use of the app. The clinical trial is inviting 350 of its users, between age 22 and 75, to complete the program’s six modules within the specified nine-week period. But the company is also following-up after 6, 8, and 14 months to gauge Somryst’s effects on sleep patterns long after the program’s end, and is assessing engagement and adherence to the program, as well as changes in anxiety or depression symptoms.

Pear Therapeutics is enrolling participants and conducting the study completely through its own connected-patient network, which it says allows for a decentralized, “site-less” study, where all data are collected remotely. This approach, says the company, is also better suited for this time of Covid-19 travel and commerce restrictions, as well as the stresses of the pandemic.

“Insomnia, anxiety, and depression are on the rise due to the Covid-19 pandemic,” says Yuri Maricich, chief medical officer at Pear Therapeutics in a company statement. Maricich adds that cognitive behavioral therapy for insomnia, or CBTi, “is considered first-line treatment for chronic insomnia, but the majority of people do not have access to nor receive the recommended treatment. By delivering CBTi digitally, we can learn from people with chronic insomnia, address their critical needs, and remove the barriers for accessing guideline recommended treatment.”

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