Head-worn low intensity focused ultrasound (LIFU) device for enhancing sleep in substance use disorder (SUD)

Project Summary While the addiction epidemic within the United States continues to grow, our ability to manage and treat addiction as a complex, multifaceted disease remains limited. Individuals with Substance Use Disorder (SUD), including Opioid Use Disorder (OUD), are particularly vulnerable to relapse not only because of the acute and severe onset of withdrawal symptoms, but also chronic symptoms which can persist throughout the individuals’ lifetime. Insomnia and sleep dysfunction represent the most severe and pervasive symptoms of both phases of withdrawal and persist despite treatment. Sleep dysfunction experienced by individuals with OUD is exceptionally anxiety-provoking and life-disrupting and is frequently a causative factor in a patient’s relapse. Sleep dysfunction in OUD is characterized by not only a deficiency in the total amount of sleep, but also a marked disruption of sleep architecture, with significant slow wave sleep (SWS) loss and fragmentation. In patients with severe withdrawal, sleep may consist almost entirely of brief periods of rapid eye movement (REM), with little SWS sleep, interrupted by numerous awakenings. Remedying insufficient sleep quality in OUD would likely increase the probability of recovery by preventing relapse. Unfortunately, commonly prescribed sleep medications have sedative and hypnotic effects with a risk of dependency too great for patients with OUD. New non-pharmacological interventions to augment sleep are currently a critical unmet medical need. Low intensity focused ultrasound (LIFU) has recently emerged as a potent tool for non-invasive stimulation or suppression of intact brain circuits with great potential for treating a range of psychiatric disorders. Ultrasound (US) beams can be focused onto specific deep regions of the brain without impacting surrounding tissue, substantially reducing undesirable off-target effects present with medications or electrical and magnetic stimulation. Unfortunately, the current technology used in LIFU research is limited to in-hospital use because of formfactor and required real-time, clinician-guided MRI, and, therefore, does not readily translate to routine addiction treatment. Attune Neurosciences was founded to develop novel LIFU technologies capable of translating research findings into a viable, non-invasive option to treat sleep and substance use disorders at home. In this Phase I SBIR, we will reconfigure our existing head-worn LIFU device to reduce the form-factor of the front EEG components by transitioning to a flexible circuit design and interchangeable front band that is more conformal to participants foreheads (Aims 1 & 2). This will be followed by a 7-night form-factor and usability study with subjects recruited from an outpatient addiction treatment facility and who are currently in recovery (Aim 3). Their input will be used to inform the final design of our wearable headband-style device that can ultimately be used to treat multiple aspects of addiction such as drug craving and underlying sleep disorders.