FDA OKs App That Disrupts Nightmares Associated With PTSD

The Food and Drug Administration (FDA) has approved the marketing of NightWare—artificial intelligence software shown to reduce sleep disturbances in people experiencing nightmares related to posttraumatic stress disorder (PTSD) or nightmare disorder.

In May 2019 NightWare received the FDA’s breakthrough device status designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

NightWare uses artificial intelligence software installed on an Apple Watch to monitor the user’s heart rate and movement while sleeping. When NightWare detects that the user is experiencing a nightmare based on its analysis of heart rate and body movement, the device emits a vibration through the Apple Watch before the nightmare reaches a severity that would awaken the user.

The device was evaluated in a 30-day randomized, sham-controlled trial of 70 patients, according to the FDA release. The researchers used two versions of the Pittsburgh Sleep Quality Index scale to compare outcomes among participants in the sham group (wore the device but received no stimulation during nightmares) with those in the active group (wore the device and received stimulation during nightmares). “Both the sham and active groups showed improvement on the sleep scales, with the active group showing greater improvement than sham,” the FDA reported.

According to a press release by NightWare Inc., a multisite randomized, sham-controlled trial remains ongoing with a planned enrollment of 240 patients. NightWare is available by prescription only and is intended for home use.

“NightWare is not a standalone therapy for PTSD. The device 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,” the agency continued.

For related information, see the Psychiatric News article “Digital Nightmare Therapy Receives Breakthrough Designation.”

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Sleep Disorders May Be Missed in Patients With Psychosis

Sleep disorders appear to be common in patients with psychosis, but few appear to be receiving sleep assessments or treatment for such disorders, suggests a report in Schizophrenia Bulletin.

“Taking sleep disorders in psychosis seriously may have important benefits,” Sarah Reeve, D.Phil., of the University of Oxford and colleagues wrote. “Recent manipulation studies have demonstrated that simulating insomnia increases psychotic experiences, and, conversely, treating insomnia reduces psychotic experiences. … [B]y improving sleep it may be possible to improve psychosis, representing an exciting new treatment target.”

For the study, Reeve and colleagues recruited patients aged 18 to 30 who had received a diagnosis of nonaffective psychotic disorder and outpatient clinical services. The researchers used the Diagnostic Interview for Sleep Patterns and Disorders (DISP) and information obtained from sleep diaries and wrist-based activity monitoring devices to assess the presence of sleep disorders in these patients. If the patient met criteria for diagnosis or positive screen for a sleep disorder, they were then asked whether they had ever discussed the issue with a medical professional and whether they received treatment for the disorder.

Of the 60 patients included in the study, 48 (80%) received a positive screen or diagnosis for at least one sleep disorder. The most common sleep diagnoses were insomnia (n=30, 50%) and nightmare disorder (n=29, 48.3%), but as the authors noted, “there was a broad range of sleep issues presenting in this group and comorbidity was high, with an average of 3.3 sleep disorders per patient.”

Patients with at least one sleep disorder reported more severe paranoia, hallucinations, depression, and anxiety compared with those who did not report a sleep disorder (as assessed by Specific Psychotic Experiences Questionnaire and Depression Anxiety and Stress Scale). The researchers found that over half of the sleep disorders had been discussed with a clinician but almost three-quarters had received no treatment.

“Diagnostic systems such as DSM-5 recommend that sleep problems should be assessed and treated irrespective of other psychiatric comorbidities. This does not appear to be happening in psychosis services,” Reeve and colleagues wrote. “[I]ndependent of any relationship with psychotic experiences, our view is that the assessment and treatment of sleep disorders among those with psychosis merits greater clinical attention.”

For related information, see the Psychiatric News article “Brains of People With Insomnia Stay More Active During Sleep.”

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