NightWare is the first and only FDA-cleared, prescription-only digital therapeutic system indicated for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from Nightmare Disorder or have nightmares from Post-Traumatic Stress Disorder (PTSD). It is classified as a Class II medical device.
The system utilizes a proprietary, patented artificial intelligence (AI) algorithm running on a dedicated, closed-system kit that includes a preprogrammed Apple Watch and iPhone. The Apple Watch monitors the user’s body movement (accelerometer, gyroscope) and heart rate in real-time. The AI analyzes this biometric data to create a unique sleep profile and calculate a "stress index." When the system detects the onset of a nightmare, it delivers a gentle, vibrotactile intervention (vibration) through the Apple Watch to interrupt the nightmare without fully waking the user.
NightWare is intended for home use and should be used in conjunction with prescribed medications and other recommended therapies for PTSD, as it is not a standalone treatment. Clinical trial data has demonstrated that NightWare can help patients with Nightmare Disorder improve their sleep quality, with improvements seen in as little as two weeks. The company primarily targets healthcare providers and payers, including the VA and DoD, to provide access to patients, especially veterans and active-duty service members.