Dive Brief:
• A digital therapeutic that monitors heart rate and motion during sleep in patients who suffer from nightmares and then delivers gentle vibrations designed to reduce the sleep disturbances has received FDA De Novo marketing authorization, the agency said Friday.
• The technology, from Minneapolis-based startup Nightware, uses an Apple Watch and iPhone that send data throughout the night to the company's server. A proprietary algorithm uses artificial intelligence to create a sleep profile for the patient, and the system detects when a nightmare is happening by analyzing heart rate and body movement.
• FDA said the authorization was supported by a 70-participant randomized trial across 30 days that showed greater improvement on sleep scales for people who received the treatment than for those in a sham group who wore the device but got no vibratory stimulation.
Dive Insight:
The De Novo authorization marks the latest in a string of FDA nods for digital therapeutics, a class of devices a sector trade group says leverage software to provide "evidence-based therapeutic interventions" across a range of disease states and stages. Often, they're meant to be used in tandem with other treatments. This past summer FDA OK'd the first video game-based therapeutic, an ADHD treatment from Akili Interactive Labs.
Nightmares have been linked to increased suicidality and risk for heart disease and diabetes, in addition to cognitive difficulties such as memory loss, anxiety and depression. About seven or eight of every 100 people will experience PTSD in their lives, according to the National Center for PTSD, a U.S. Department of Veterans Affairs program. People who have experienced or witnessed a dangerous or traumatic incident can develop physical and cognitive symptoms.
Nightware's personalized treatment for nightmare disorder and nightmares related to PTSD detects the sleep disturbance at its onset and intervenes using vibrations to arouse the sleeper without waking them. The patient's nightmare is interrupted but circadian sleep pattern continues, allowing more restful sleep, according to the company.
The three-year-old company's smartphone application gained FDA's breakthrough device designation in May 2019. The process aims to speed development and review of devices with potential to improve treatment of serious or life-threatening conditions when there is no approved therapy offering similar benefits.
FDA reviewed the Nightware product through the De Novo premarket review pathway for low- to moderate-risk devices. The agency said it is establishing special controls to provide reasonable assurance of safety and effectiveness for such devices that include labeling and performance testing requirements.
The decision also establishes a new regulatory classification for prescription digital therapy devices designed to reduce sleep disturbance associated with psychiatric conditions. Subsequent devices may go through FDA's 510(k) premarket process to gain marketing authorization by demonstrating substantial equivalence.
Nightware's study evaluated safety using validated measurements of suicidality and sleepiness, finding no changes in either measure for both the sham and active groups, FDA said. Sleep was assessed with two versions of the Pittsburgh Sleep Quality Index scale using a self-rated questionnaire to assess sleep quality, including a version intended for patients with PTSD.
FDA said the device is not a standalone therapy for PTSD and should be used in conjunction with prescribed medications and other recommended therapies.
