Summary The Fisher Wallace Stimulator, a cranial electrical stimulator (CES) headband, has been used to treat insomnia, anxiety, and depression. It was previously known as the LISS Cranial Stimulator which was FDA cleared in 1990 to treat insomnia and/or anxiety, and the company is rebranding to support a newer model called “OAK”. However the device currently has an FDA recall, reportedly due to not submitting required Medical Device Reporting within 30 days that serious adverse events (SAE) had occurred with battery heating problems. It reportedly increases total sleep time for most users. Wo ..read more

Summary There are both adult (Restore 1 and 2) and pediatric (Rest Go, Rest 2nd gen, Rest + 2nd gen) Hatch products. All are (sound, light, and alarm) nearables with apps. Hatch Restore 1 offers music, sounds, stories, mind/body exercises, bedside lighting, and light alarms that can be customized. Restore 2 offers these, more personalized tools, a soft light diffused through linen (versus the Restore 1 opal dome light), and more speaker, sound, light, and alarm customizable options. Rest Go has 10 sounds and is a portable clip-on (such as for a crib or stroller) with app. Rest 2nd gen is a bed ..read more

Summary URGOnight consists of a wearable EEG headband connected to an app via Bluetooth. URGOnight has two dry measuring electrodes over the sensorimotor cortex in positions C3 and C4, with reference and ground positioned on the left and right mastoids. The headband EEG data transfer to the app in real-time to allow the user to perform independent neurofeedback training. In addition to the neurofeedback program, the app provides daily sleep quality and sleep hygiene advice, questionnaires, and a sleep diary. The app also allows users to track progress, set personal goals, and set device use re ..read more

Summary Modius Sleep is a prescription headset for adult insomnia treatment. It resembles a headband across the top of the head, with wires which are applied over the mastoid bone bilaterally. Users are recommended to sit in a chair at approximately 8-9pm (bedtime 1-5 hours later), apply the headset, and try to relax. The person reportedly may feel a swaying or rocking motion like being on a boat or after a glass of wine, or may feel a light tingling/prickling sensation behind the ears. Users may wear it for 30 to 60 minutes, for 5-7 nights per week, beginning at setting 1 for the first 5 days ..read more

Members Only Resource This content is provided exclusively to our members. Log in or Join Today to access this and the other great membership benefits of the American Academy of Sleep Medicine. If you're already logged in and still cannot access this content you may need to renew your membership to gain access. The post Sleep Medicine Weekly Insider – April 20, 2024 appeared first on American Academy of Sleep Medicine – Association for Sleep Clinicians and Researchers ..read more

AASM staff participated in the 2024 CMS Quality Conference, #QualCon24, April 8-9. The conference’s theme was, “Resilient and Ready Together: Creating an Optimal Environment for Quality Healthcare for Individuals, Families, and Communities.” This year CMS focused on several topics, which included: Advancing Health Equity Collecting and Using Quality Data Engaging Partners and Communities Expanding Access to Quality and Affordable Behavioral and Physical Healthcare Healthcare System Resiliency and Readiness High Reliability and Quality Improvement New Technology and Innovation Patient Safety ..read more

Summary Somnee, an electronic sleep aid headband, is worn for 15 minutes before bedtime while reportedly delivering personalized transcranial alternating current stimulation. The device purportedly uses proprietary EEG+ technology to read the user’s EEG patterns and personalize the neuromodulation (tACS) delivery. The 15-minutes pre-bedtime sessions are integrated into bedtime routines, with a goal of improving sleep efficiency. The brainmapping process involves a 7 night device and proprietary EEG technology learning period, 14 day personalized phase, and an indefinite adaptive phase. The man ..read more

Summary Headspace app allows the user to access meditation and mindfulness exercises, sleepcasts, and educational materials with the goal to alleviate stress, anxiety, and insomnia. There are 5 sections: Today (personalized content), Meditate (one-off or muliti-part course guided meditations), Sleep (guided meditations, stories, relaxing sounds, sleep-radio), Move (stretches, yoga, dance and cardio workouts), and Focus (music, soundscapes, meditations). There are options for daily nudges, adding buddies, customizing meditations, and tracking the user’s progress. It is available in several lang ..read more

Summary The HoneyNaps platform includes SOMNUM, an AI software as a medical device (SaMD) that is FDA cleared (8/16/23), My SOMNUM, a non-contact nearable that includes sleep analysis and coaching, and SOMNUM Medella, a digital treatment for insomnia. SOMNUM software is FDA cleared for the diagnosis of sleep and respiratory disorders for adults. SOMNUM has automated scoring with manual rescoring. Obstructive, central, mixed, and hypopneas must be manually scored by a physician. As the AHI output is not apnea type specific, it should not be used for management decisions related to diffentiating ..read more

Members Only Resource This content is provided exclusively to our members. Log in or Join Today to access this and the other great membership benefits of the American Academy of Sleep Medicine. If you're already logged in and still cannot access this content you may need to renew your membership to gain access. The post Sleep Medicine Weekly Insider – April 13, 2024 appeared first on American Academy of Sleep Medicine – Association for Sleep Clinicians and Researchers ..read more