FDA OKed Insomnia Digital Therapy Begins Enrolling Participants for Real-World Impact Trial

Pear Therapeutics Inc has enrolled the first participant enrolled in an open-label, decentralized clinical trial (called the DREAM study) evaluating Somryst, an FDA-authorized prescription digital therapeutic (PDT) for the treatment of chronic insomnia. The DREAM study will enroll approximately 350 adults in the United States with chronic insomnia for nine weeks of digitally-delivered treatment and collect data in a real-world insomnia population.

Pear has developed its own decentralized and fully virtual clinical trial infrastructure for participant recruitment, screening, consent, enrollment, follow up, and progress tracking, which will be used for the DREAM study. This decentralized, fully site-less approach allows clinical studies such as DREAM to advance rapidly even as COVID-19 constrains the ability to safely conduct clinical studies and real-world research involving in-clinic visits. Eligible participants across the United States can enroll without ever needing to attend a physical clinical site.

The aim of the DREAM study is to further examine the real-world impact of Somryst on chronic insomnia, depression, and anxiety symptoms in patients with chronic insomnia. DREAM will also collect self-reported healthcare utilization data, including quality of life and work attendance and productivity, during the study and up to one year follow up. The DREAM study will recruit participants between 22 and 75 years old, inclusively, who meet the criteria of chronic insomnia as defined by an Insomnia Severity Index (ISI) score of 8 or above and insomnia symptoms for at least 3 months, and have access to a mobile device.

“Insomnia, anxiety, and depression are on the rise due to the COVID-19 pandemic,” says Yuri Maricich, MD, chief medical officer at Pear Therapeutics, in a release. “Cognitive behavioral therapy for insomnia (CBT-I) is considered firstline treatment for chronic insomnia, but the majority of people do not have access to nor receive the recommended treatment. By delivering CBT-I digitally, we can learn from people with chronic insomnia, address their critical needs, and remove the barriers for accessing guideline recommended treatment.”

from Sleep Review https://ift.tt/2OCqsQd