Pear Therapeutics is emerging as a leader in the area of digital therapeutics. The company was the first to obtain FDA approval for a novel prescription digital therapeutic that was designed to help patients suffering from substance use disorder.
Last year, Pear Therapeutics obtained FDA’s approval for Somryst, its prescription digital therapeutic for the treatment of chronic Insomnia.
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Now the company is collaborating with Mayo Clinic on a new clinical trial of hundred patients to assess the real-world effectiveness of a mobile-delivered, digital therapeutic device delivering cognitive behavioral therapy for Insomnia.
This new study will use a novel patient-centered data-sharing platform with linkage to Fitbit. The new platform with Fitbit integration is called “Hugo”.
Half of the cohort with insomnia will receive the Somryst digital therapeutic with linkage to the Hugo platform and Fitbit (Inspire 2) and half of the patients with insomnia will not receive the Somryst but will receive a Fitbit and be enrolled in the Hugo platform.
The treatment duration will be 9 weeks with a 21-, 35-, and 61-week follow-up.
The Somryst intervention will deliver CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Additionally, the Hugo platform will be used to collect patient-generated engagement data, healthcare utilization outcomes, and patient activity/clinical outcomes.
The new study is being sponsored by Yale University.
The new clinical trial was announced this week and marks another win for wearable integration in the field of digital health and therapeutics.
As more and more folks start using wearables such as the Fitbit and Apple Watch on a regular basis, digital health companies such as Pear Therapeutics are exploring ways to link their product offerings with these wearables.
According to the American Sleep Association: Nearly 70 million Americans have a sleep disorder. Insomnia is the most common sleep disorder, with 30% of adults experiencing short-term insomnia. About 10% of people have long-lasting insomnia.
Fitbit has about 30 million users with only half a million paying subscribers on its premium platform.
Fitbit currently offers sleep monitoring features on its platform. The company’s new software update can also detect snoring and assign a sleep profile based on a user’s sleep patterns.
Integrations such as these, if available, will help strengthen Fitbit’s premium offerings in the long term and will attract new users who are looking to proactively manage their health beyond measuring the number of daily steps.