On Friday, the U.S. Food and Drug Administration (FDA) granted a De Novo clearance to NightWare for its Apple Watch and iPhone app designed a digital therapeutic device to improve the sleep quality in people with nightmare disorder or nightmares caused by post-traumatic stress disorder (PTSD).
The digital therapeutic device, developed by NightWare, monitors heart rate and movement to detect any kind of disturbances during sleep and then delivers gentle vibration to interrupt a nightmare without affecting the sleep of the user.
The device is intended for home use among adults aged 22 and above. It will be available only by prescription.
The FDA has clearly mentioned that the device is not the only therapy for patients who have nightmare disorder induced by PTSD. The agency said it should be used along with other medications prescribed by a doctor.
The device is not intended for patients who have a history of sleepwalking or violence during their nightmares, according to the FDA.
CEO of NightWare Grady Hannah said that the device is currently available on a limited basis through a doctor’s recommendation. He said the company is aiming for a wider launch in the first quarter of 2021.
“Qualifying patients who receive a prescription will receive an Apple Watch kit pre-loaded with the NightWare software through the mail,” Hannah said.
The FDA granted the De Novo clearance after reviewing data from a 30-day trial of 70 patients assigned to receive either the NightWare app or an Apple Watch with no vibratory stimulation.
The trial found that both groups demonstrated improvements in self-reported sleep quality.
NightWare is now planning to conduct another trial, enrolling 240 patients from multiple Department of Veterans Affairs hospitals. The trial is expected to get over in the second half of 2021.
Dr. Carlos Peña, “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.”
Dr. Peña is the director of the Office of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health.
“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,” he added.
Hannah said, “NightWare was founded and built to support veterans and active duty service members who have so unselfishly given of themselves to preserve our freedoms, and suffer emotional, physical, and mental distress as a consequence of severe nightmares.”
“Helping our current and past military members and all people with this condition is NightWare’s mission and we are excited to introduce this first and only therapeutic for nightmares,” he continued.
“The use of the NightWare Therapeutic Platform provides an effective treatment for clinically significant nightmares; avoids drug side-effects; and reduces the need for time-intensive and often-unavailable psychological therapy sessions,” he added.
“In parallel, we are building out our sales force and commercial distribution partners to be ready to fulfill demand once access determinations are finalized,” Hannah said.
Last year, Hannah and Dr. Daniel Karlin told Mobi Health News that the company is “keeping in mind the larger market opportunity among providers, payers, support groups and other organizations whose members might be at risk of PTSD nightmares not resulting from combat.” The article originally appeared on Mobi Health News.
