FDA Allows Marketing of New Device to Reduce Nightmare-Related Sleep Disturbances in Adults

The US Food and Drug Administration (USFDA) has allowed the marketing of a new sleep-disturbing device for temporary nightmares in adults 22 years and older with nightmares or post-traumatic stress disorders (PTSDs). The device offers gentle touch vibration based on an analysis of cardiac rates and sleep movement.

“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need,” said Carlos Peña, Ph.D., director of the Department of Neurology and Physical Medicine at the FDA Devices and Radiological Health Centre. “Today’s authorization offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares.”

PTSD is a disorder in some people who have experienced a shocking, frightening, or dangerous occurrence. People may have experienced a number of trauma reactions from which they will recover over time. However, PTSD is diagnosed with those who continue to experience symptoms that may include sleep problems and nightmares. Several drugs may help address specific symptoms of PTSD. Besides, an experienced mental health professional can help people find a treatment plan that meets their symptoms and needs.

The Nightware is an Apple Watch and Apple iPhone digital therapy device that is configured and logged in to a Nightware software application and server. The Apple Watch sensors monitor cardiovascular movement and heart rate during sleep. These are forwarded to the Nightware server, and the device uses a proprietary algorithm to create a unique patient sleep profile. Based on cardiac rate and body motion analysis, vibrations are delivered using the Apple Watch when detecting a patient suffering from a nightmare. Nightware is available on prescription only and is for home use only.

This device was studied in a randomized, sham-controlled study of 70 patients for 30 days. Sham therapy is an inactive treatment or procedure designed to imitate therapy in a clinical trial as closely as possible. Patients in the sham group had worn the devices, but no vibrational stimulations were provided. Safety was evaluated with validated suicidality and sleep measurements, and no changes occurred in either group during the course of the study. The assessment of sleep was carried out using two versions of the Pittsburgh Sleep Quality Index, a self-rated evaluation of sleep quality questionnaire, with a scale version intended for PTSD patients. Both the sham and the active groups showed improvement in sleeping scales, with the active group showing greater improvement. Evidence shows that the likely advantages outweigh the likely risks.

By Ching-Hsu Yang, Ph.D. Candidate, National Taiwan University

Editor: Rajaneesh K. Gopinath, Ph.D.

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References

1. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-device-designed-reduce-sleep-disturbance-related-nightmares-certain-adults
2. https://www.apple.com/tw/watch/?afid=p238%7CspoMq4twe-dc_mtid_18707vxu38484_pcrid_465660578624_pgrid_16718749022_&cid=aos-tw-kwgo-watch–slid—product–
3. https://night-ware.com/

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