FDA grants clearance for NightWare app designed to reduce PTSD-related nightmares

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FDA grants De Novo clear­ance to pre­scrip­tion Apple Watch app for night­mare dis­or­der (Mobi­Health News):

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.

The FDA Announcement:

FDA Per­mits Mar­ket­ing of New Device Designed to Reduce Sleep Dis­tur­bance Relat­ed to Night­mares in Cer­tain Adults (press release):

Today, the U.S. Food and Drug Admin­is­tra­tion per­mit­ted mar­ket­ing of a new device intend­ed 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). The device pro­vides gen­tle vibra­tion through touch based on an analy­sis of heart rate and motion dur­ing sleep.

“Sleep is an essen­tial part of a person’s dai­ly rou­tine. 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,” said Car­los Peña, Ph.D., direc­tor of the Office of Neu­ro­log­i­cal and Phys­i­cal Med­i­cine Devices in the FDA’s Cen­ter for Devices and Radi­o­log­i­cal Health …

This device 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.

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