PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): A Protocol for a Pragmatic Randomized Controlled Trial
Authors: Dreyer Rachel P. , Berkowitz Alyssa , Yaggi Henry Klar , Schneeberg Lynelle , Shah Nilay D. , Emanuel Lindsay , Kolla Bhanuprakash , Jeffery Molly , Deeg Mark , Ervin Keondae R. , Thorndike Frances , Ross Joseph S. 
Published: March 2022

ABSTRACTIntroductionCognitive behavioral therapy for insomnia (CBT-I) is effective at treating chronic insomnia, yet in-person CBT-I can often be challenging to access. Prior studies have used technology to bridge barriers but have been unable to extensively assess the impact of the digital therapeutic on real-world patient experience and multi-dimensional outcomes. Among patients with insomnia, our aim is to determine the impact of a Prescription Digital Therapeutic (PDT) (PEAR-003b, FDA-authorized as Somryst; herein called PDT) that provides mobile-delivered CBT-I on patient-reported outcomes (PROs) and healthcare utilization.Methods and AnalysisWe are conducting a pragmatically designed, prospective, multi-center randomized controlled trial that leverages Hugo, a unique patient-centered health data-aggregating platform for data collection and patient follow-up from Hugo Health. A total of 100 participants with insomnia from two health centers will be enrolled onto the Hugo Health platform, provided with a linked Fitbit (Inspire 2) to track activity, and then randomized 1:1 to receive (or not) the PDT for mobile-delivered CBT-I (Somryst). The primary outcome is a change in the insomnia severity index score (ISI) score from baseline to 9-weeks post-randomization. Secondary outcomes include healthcare utilization, health utility scores, and clinical outcomes; change in sleep outcomes as measured with sleep diaries; and a change in individual PROs including depressive symptoms, daytime sleepiness, health status, stress, and anxiety. For those allocated to the PDT, we will also assess engagement with the PDT.Ethics and DisseminationThe Institutional Review Boards at Yale University and the Mayo Clinic have approved the trial protocol. This trial will provide important data to patients, clinicians, and policymakers about the impact of the PDT device delivering CBT-I on PROs, clinical outcomes, and healthcare utilization. Findings will be disseminated to participants, presented at professional meetings, and published in peer-reviewed journals.Trial Registration NumberNCT04909229Strengths and limitations of this studyThis is the first controlled study to examine the impact of a mobile-delivered, prescription digital therapeutic (PDT) delivering Cognitive Behavioral Therapy for Chronic Insomnia (i.e., PEAR-003b, FDA-authorized as Somryst) on real-world patients outcomes of care that includes a multi-dimensional analysis of patient benefit across guideline-recommended health domains (e.g., insomnia severity index) and healthcare utilization (e.g., emergency department visits).This randomized clinical trial will use Hugo, a novel patient-centered health data-aggregating platform for data collection and patient follow-up, which gathers and collates patient-reported outcomes, clinical outcomes, and healthcare utilization metrics for real-world patients with chronic insomnia. The participant has ownership over their data and contributes it to research.Future studies should focus on patients with chronic insomnia as well as co-morbid conditions such as major depression and whether sleep improvements can be sustained, particularly in the long-term.