FDA grants De Novo clearance to prescription Apple Watch app for nightmare disorder

NightWare's digital therapeutic monitors a wearer's heart rate and movement to detect disturbances during sleep, and delivers gentle vibrations to interrupt a nightmare without waking the user.
By Dave Muoio
02:47 pm

The FDA granted Minneapolis-based NightWare a De Novo clearance on Friday for its Apple Watch and iPhone app designed to improve the sleep quality of those experiencing nightmare disorder and nightmares related to PTSD.

The digital therapeutic – which received breakthrough designation from the agency last year – uses the Watch's sensors to track the heart rate and movement of users as they sleep. After establishing a baseline profile for the patient within one or two nights' sleep, the machine learning algorithm spots heart rate or movement abnormalities presumably caused by a nightmare. The application then vibrates the smartwatch just enough to interrupt the wearer's dreaming, but not enough to wake them up or disrupt their circadian sleep cycle.

The digital therapeutic is intended for home use among adults aged 22 years or older and will require a prescription. The agency stressed in the announcement that it is not a standalone therapy for PTSD and should be used alongside other prescribed medications or recommended therapies. It is also not intended for patients with a history of sleepwalking or violence during their nightmares, according to the announcement.

In an email Q&A, NightWare CEO Grady Hannah said that the product is currently available on a limited basis through physician recommendation, and that 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, he said.

To make its decision, the FDA reviewed data from a 30-day trial of 70 patients randomly assigned to receive either the NightWare app or an Apple Watch with no vibratory stimulation. Both groups demonstrated improvements on self-reported sleep quality, although the benefit was greater for those provided with the product.

NightWare also noted that it is currently conducting a randomized, placebo-controlled trial of the therapy that seeks to enroll 240 patients from multiple Department of Veterans Affairs hospitals. This study is slated to wrap up in the second half of next year.


“Sleep is an essential part of a person’s daily routine," Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. "However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need. 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.”

In addition to the relatively low risk of the digital therapeutic, NightWare's announcement highlighted data linking PTSD with higher rates of suicide among veterans.

“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," Hannah said in a statement. "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. ... 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."

Hanna said that the company is currently working to secure product committee reviews within the VA healthcare system and the Department of Defense Military health System, which would accelerate access to the platform among members of those departments. 

"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. 

Speaking to MobiHealthNews last year, Hannah and Dr. Daniel Karlin, NightWare's chief medical officer, also said 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. Hannah reaffirmed today that his company still intends to expand the availability of NightWare to commercial plans "in the future."


Across regulation, coveragecommercialization and adoption, 2020 has opened several new doors for digital therapeutics.

The FDA opened the floodgates for in-development behavioral and psychiatric products during the course of the COVID-19 emergency, and provided De Novo and 510(k) green lights to Akili Interactive Labs and Pear Therapeutics, respectively. These two companies and their peers have spoken at length about the increased demand for digital health products (and behavioral health therapies, in particular) during the pandemic, while a recent market report anticipates that digital therapeutics and wellness apps will ride this wave of interest to 1.4 billion users by 2025.


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