For sleep specialists looking for more data on Somryst, Pear Therapeutics Inc’s prescription digital therapeutic for the treatment of insomnia in adults, two abstracts presented at World Sleep 2022 provide data on its efficacy at six months and on its use in older adults.
“Today, many people face barriers to accessing care so the opportunity to provide patients with 24/7 virtual access to proven treatment options is more important than ever,” says Yuri Maricich, MD, chief medical officer & head of development at Pear Therapeutics, in a release. “It’s critical to examine the impact of prescription digital therapeutics among people with chronic insomnia, particularly given the toll lack of sleep can take on day-to-day activities and overall quality of life, including leading to depression, suicidality, hypertension, and even heart attacks.”
Interim data from the DREAM study (NCT04325464), a remote, virtual, open-label, decentralized clinical trial evaluating Somryst, analyzed in mid-Q1 2022, had 991 patients enrolled to date. In 779 patients who completed end-of-treatment (EOT), the population achieved statistically significant and clinically meaningful reductions in insomnia severity (ISI), sleep onset latency (SOL), and wake-after-sleep onset (WASO) from baseline to post-treatment at nine weeks, and in the 193 patients who completed the 6 months follow-up, significant improvements in ISI, SOL, and WASO, were all maintained through six months. As part of its PearCreate platform, Pear has developed its own decentralized and fully virtual clinical trial infrastructure for participant recruitment, screening, consent, enrollment, follow up, and progress tracking, which was used for the DREAM study.
Study Results Presented at S31
- Interim data showed of participants treated with Somryst, the mean ISI at baseline was 18.8 and at EOT was found to be 11.3 (Cohen’s d = 1.4 (1.3 – 1.5), and at 6 months 12.1 (Cohen’s d = 1.2 (1 – 1.4) (p<0.0001), where Cohen’s effect sizes over 1.0 are also considered large treatment effects.
- By end of treatment, 78.7% and 73.3% of participants treated with Somryst achieved the American Academy of Sleep Medicine (AASM) clinically meaningful definition of SOL remission (falling sleeping within 30 minutes or less) and/or WASO remission (waking up during the night for 30 or fewer minutes), respectively.
These results are interim, additional results will be reported on in the future, upon completion of enrollment and patients reaching subsequent follow-up assessment periods.
“The ability to capture real-world data in a fully remote setting due to the COVID-19 pandemic allowed us to really understand the value that access to remote treatment options have in successfully treating chronic insomnia,” says Charles M. Morin, PhD, professor, Laval University, and Director, Centre d’étude des troubles du sommeil in Québec, Canada, in a release. “These results demonstrate that cognitive behavioral therapy, the recommended first line treatment of care for chronic insomnia, can be effectively delivered through a PDT like Somryst, helping patients treat their chronic insomnia.”
Specific Study Results for O23
An additional study evaluating older adults (55 years of age or older) with chronic insomnia was also presented. In this trial, patients used an earlier version of Somryst (previously called SHUTi, that was tailored for older adults, and so is called SHUTi-OASIS). Most participants were female (68.5%) with an average age of 66.3 years and 13.5 years of sleep difficulties.The majority of the 311 older adults with insomnia (OAWI) completed all six treatment cores (85%).
- Results found treated participants achieved significant reductions in ISI score (15.9 at baseline, 10.0 at ten weeks, 9.1 at six months and 8.9 at 12 months) compared to participants who received PE (16.2 at baseline, 15.1 at ten weeks, 14.0 at six months and 13.2 at 12 months) (p<.001).2
- Similar patterns in WASO, SOL, sleep efficiency and sleep quality were also demonstrated.
“These results provide strong evidence that older adults living with insomnia both use and obtain significant benefits from an interactive, remote program to treat their chronic insomnia, without needing special assistance,” says Lee Ritterband, PhD, professor and director of the Center for Behavioral Health & Technology, University of Virginia School of Medicine in Charlottesville, Va, in a release. “These results demonstrate the value of remote interventions for chronic insomnia for older adults living with insomnia who may not otherwise have access to clinically validated treatment options like CBTi.”