C hronic pain, defined as recurrent or persistent pain lasting more than 3 months, is a prevalent condition among children and adolescents with capacity for significant effects on overall functioning and quality of life. Estimated prevalence of chronic pain in US children and adolescents ranges between 6% and 38% and a major proportion will continue to struggle with chronic pain in adulthood. 1 Annual costs of chronic pain among American youth are estimated to be $11.8 billion, exceeding the costs of other major chronic conditions, including pediatric asthma and obesity. 2 When attempting to promote pain management, attention must be devoted to different behavioral, psychological, and physiological factors that may serve to promote or inhibit pain coping.Sleep is one important health habit to review when addressing quality of life in children with pain. This article briefly reviews the relationship between pain and sleep and provides assessment and intervention approaches that can be incorporated into practice.

IntroductionCognitive behavioural 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 multidimensional outcomes. Among patients with insomnia, our aim is to determine the impact of a prescription digital therapeutic (PDT) (PEAR-003b, FDA-authorised as Somryst; herein called PDT) that provides mobile-delivered CBT-I on patient-reported outcomes (PROs) and healthcare utilisation.Methods and analysisWe are conducting a pragmatically designed, prospective, multicentre randomised controlled trial that leverages Hugo, a unique patient-centred health data-aggregating platform for data collection and patient follow-up from Hugo Health. A total of 100 participants with insomnia from two health centres will be enrolled onto the Hugo Health platform, provided with a linked Fitbit (Inspire 2) to track activity and then randomised 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 from baseline to 9-week postrandomisation. Secondary outcomes include healthcare utilisation, 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 utilisation. Findings will be disseminated to participants, presented at professional meetings and published in peer-reviewed journals.Trial registration numberNCT04909229.

Introduction: Cognitive 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 Analysis: We 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 Dissemination: The 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.

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