Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia

Leveraging patient-generated health data, this project is assessing the impact of a mobile-delivered, prescription digital therapeutic (PDT) (Somryst) delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) for real-world patients with chronic insomnia.

Insomnia is one of the most prevalent health concerns and imposes a significant physical, behavioral and financial burden on patients’ lives. Up to 50% of the general adult population experience insomnia symptoms, with 12-20% meeting criteria for chronic insomnia. Adults suffering from insomnia also have a higher likelihood of comorbid conditions such as depression, resulting in a reduced quality-of-life and higher rates of morbidity and mortality. CBT for insomnia is the recommended first line treatment for chronic insomnia, but many patients encounter treatment barriers, including a limited number of trained providers. The goal of this Test-Case is to conduct a multi-center randomized controlled trial to collect and evaluate real-world data alongside clinically-validated measures of insomnia to yield a multidimensional analysis of patient benefit from a mobile-delivered CBT-I prescription digital therapeutic.

Using Hugo Health, a patient-centered health data sharing platform for data collection and aggregation, this study is gathering and collating patient-reported outcomes, healthcare utilization data and data from personal digital devices. 100 patients with chronic insomnia are being randomly allocated to receive the PDT delivering CBT-I or usual care and followed for 61 weeks. The primary study endpoints are self-reported online ratings of insomnia severity. Secondary endpoints include rate of healthcare utilization, change in sleep outcomes and change in patient-reported outcomes of sleep quality.