Project Abstract Millions of pediatric patients with attention-deficit/hyperactivity disorder (ADHD) suffer from sleep disturbances that significantly degrade their quality of life and amplifies the heavy emotional and financial burden on caregivers. Restless Legs Syndrome (RLS) is a likely (and treatable) factor for the sleep disturbance in these patients. Oral iron therapy has been shown to improve both sleep and ADHD symptoms in children. However, RLS is currently difficult to diagnose, particularly in pediatric patients with ADHD. The diagnosis is made clinically with subjective, patient reports and the symptoms themselves are variable across individuals. Thus, patients with ADHD who may already have difficulty with verbal expression are especially vulnerable to being misdiagnosed. RestEaze is an ankle-worn wearable technology and mobile application developed by Tanzen Medical Inc. to measure leg movements during sleep that are highly related to RLS and can serve as an objective biomarker of the condition. The device is industrially designed to be comfortably worn by the patient and washable to permit extended, nightly use. The mobile application is easy to use by the patient (or caregiver) to interact with and store data from the device. The read-out provided to the clinician provides clear, actionable information that quantifies the patients’ leg movements during sleep in reference to American Academy of Sleep Medicine standards. In sum, RestEaze directly addresses a significant unmet medical need by providing a technology that can substantially improve the diagnosis and subsequent management of RLS in pediatric patients with ADHD. The use of this technology is expected to improve the quality of life for patients with ADHD and their caregivers by directly addressing their sleep disturbance.

Project Narrative Restless Legs Syndrome (RLS) is a significant contributor to sleep problems in pediatric patients with Attention-Deficit/Hyperactivity Disorder (ADHD). Unfortunately, current medical practice results in a significant underdiagnosis of RLS in patients with ADHD, leaving them untreated or worse, treated for the wrong condition. The RestEaze technology developed in this proposal will address this gap by providing clinicians information on a patient’s leg movements during sleep which they can then use to help accurately diagnose and treat patients with ADHD who are suffering from RLS.