Pear Therapeutics has enroled the first patient in virtual real-world study with an FDA-authorised prescription digital therapeutic (PDT) to treat chronic insomnia.

Somryst, a nine-week PDT for chronic insomnia, has to be used on a mobile device such as a smartphone or tablet. It is designed to offer a neurobehavioural intervention to patients 22 years of age and older with chronic insomnia.

The open-label study will enrol around 350 adults in the US

The open-label and decentralised clinical trial, dubbed DREAM study, will enrol around 350 adults in the US with chronic insomnia to evaluate digitally-delivered treatment for nine weeks.

Pear Therapeutics will gather data in a real-world insomnia population. The company has designed its own decentralised and fully virtual clinical trial infrastructure for participant recruitment, screening, consent, recruitment, follow up, and progress tracking to be used for the study.

The decentralised and fully site-less approach enables clinical studies such as DREAM  to advance quickly even as Covid-19 constrains the ability to safely carry out clinical studies and real-world research involving in-clinic visits.

The DREAM study has been designed to further evaluate the real-world impact of Somryst on chronic insomnia, depression, and anxiety symptoms in patients with chronic Insomnia.

Pear’s trial will also gather self-reported healthcare utilisation data, including quality of life and work attendance and productivity, during the study and up to one year follow up. The trial will enrol participants between 22 and 75 years old.

Pear Therapeutics chief medical officer Dr Yuri Maricich said: “Cognitive Behavioral Therapy for insomnia (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.”

In March this year, Pear Therapeutics secured approval from the US Food and Drug Administration (FDA) for Somryst to treat adults with chronic insomnia.