NightWare Receives FDA Marketing Permission for First and Only Medical Device to Reduce Sleep Disturbances Related to PTSD-Associated Nightmares in Adults

By Staff 4 years ago

MINNEAPOLIS–(BUSINESS WIRE)–#DigitalTherapeutic–NightWare, a medical device company focused on treating people with nightmares related to post-traumatic stress disorder (PTSD) and other traumatic events, has announced it has received U.S. Food and Drug Administration (FDA) marketing permission for the NightWare™ therapeutic platform. NightWare is the first and only medical device to be 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 PTSD.1

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Clinically significant nightmares are a frequent manifestation of PTSD and sexual trauma, and studies show approximately 80% of PTSD patients experience frequent recurrent traumatic nightmares that can persist for months, if not years.2,3,4 These traumatic nightmares and nightmare disorder are an under diagnosed and undertreated condition that is associated with significantly higher rates of suicide.5

“Disruptive and persistent traumatic nightmares associated with post-traumatic stress are significantly underreported and undertreated, and there are no consistently effective treatment options,” said General Peter W. Chiarelli, U.S. Army (Retired) and advisor to NightWare. “A device such as the NightWare therapeutic platform that performs the necessary reconnaissance of the mind to identify and interrupt post-traumatic stress-associated nightmares represents a transformational step forward in how we can begin to better support our veterans and active service members suffering from this disabling condition.”

The NightWare therapeutic platform utilizes patented artificial intelligence software installed on an Apple Watch that monitors the biometric pattern of an individual’s sleep cycle to identify elevated heart rate and body movement associated with nightmares and is then able to interrupt the nightmare by arousing the patient out of the distress state via gentle vibration, prior to the nightmare reaching a severity that would awaken the individual. This feedback decreases nightmare frequency and intensity for patients and, in clinical study, NightWare was well-tolerated and sleep quality was shown to improve.1

“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 nightmares,” said Grady Hannah, chief executive officer, NightWare. “Helping our current and past military members and all people with this condition is our mission, and we are excited to introduce the NightWare therapeutic platform as the first and only device indicated as an important treatment to reduce sleep disturbances associated with clinically significant nightmares.”

The NightWare therapeutic platform was granted Breakthrough Therapy Designation by the FDA in May 2019, in recognition of its preliminary clinical evidence for the treatment of a serious condition for which there is a critical unmet need and demonstration of substantial improvement over available therapy on clinically significant endpoints.

The NightWare therapeutic platform was studied in a 30-day randomized, sham-controlled trial of 70 patients. A sham therapy is an inactive treatment or procedure that is intended to mimic as closely as possible a therapy in a clinical trial. Patients in the sham group wore the device, but no vibratory stimulation was provided. Safety was assessed using validated measurements of suicidality and sleepiness, and there were no changes in either over the course of the study in either group. Sleep was assessed with two versions of the Pittsburgh Sleep Quality Index scale, the self-rated questionnaire for assessing sleep quality, including a version of that scale that is intended for patients with PTSD. Both the sham and active groups showed improvement on the sleep scales, with the active group showing greater improvement than sham. The evidence demonstrated the probable benefits outweighed the probable risks.1 A large multi-site, randomized sham-controlled trial remains ongoing with a planned enrollment of 240 patients and is expected to be completed in H2 2021.

The NightWare therapeutic platform is available by prescription only and is intended for home use. The NightWare therapeutic platform is not a standalone therapy for PTSD. The NightWare therapeutic platform should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder, according to relevant consensus guidelines.

For additional patient and healthcare provider-specific information, please reference the instructions for use available at NightWare.com.

About NightWare

Founded in 2017, NightWare is a privately held, commercial-stage medical device company whose mission is to help people with traumatic nightmares get a more restful night’s sleep. The NightWare™ therapeutic platform is the first and only medical device to be 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 PTSD. For more information on the company and its platform, visit NightWare.com.

References:

  1. NightWare Prescribing Information. NightWare U.S. Product Information. November 2020. Minneapolis, MN: NightWare
  2. Thomas JL, Wilk JE, Riviere LA, McGurk D, Castro CA, Hoge CW. Prevalence of mental health problems and functional impairment among active component and National Guard soldiers 3 and 12 months following combat in Iraq. Arch Gen Psychiatry. Jun 2010;67(6):614-623.
  3. LeardMann CA, Smith TC, Smith B, Wells TS, Ryan MA. Baseline self reported functional health and vulnerability to post-traumatic stress disorder after combat deployment: Prospective US military cohort study. BMJ. Apr 16 2009;338:b1273.
  4. Smith TC, Ryan MA, Wingard DL, Slymen DJ, Sallis JF, Kritz-Silverstein D. New onset and persistent symptoms of post-traumatic stress disorder self reported after deployment and combat exposures: Prospective population based US military cohort study. BMJ. Feb 16 2008;336(7640):366-371.
  5. Sjöström N, Hetta J, Waern M. Persistent nightmares are associated with repeat suicide attempt: a prospective study. Psychiatry Res. 2009;170(2-3):208-211.

 

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