I cannot wait to get my hands on this study to rip it apart:
65 patients and NO statistically significant changes???? Both the sham and treated group did better???? But a "post-hoc" analysis said it works great!!!!
Results: Both groups demonstrated statistically significant within-person improvement on all measures. While the Active system was generally associated with stronger magnitude of improvement, none of the comparisons of individual measures across conditions reached statistical significance. However, a post hoc analysis excluding participants with low frequency usage demonstrated significantly better improvement in perceived sleep quality with the Active device than Sham.
Throughout the night, Apple Watch sensors monitor body movement and heart rate during sleep. These data are sent to the Nightware server and, using a proprietary algorithm, the device creates a unique sleep profile for the patient. When Nightware detects that a patient is experiencing a nightmare based on its analysis of heart rate and body movement, the device provides vibrations through the Apple Watch while the product is in use.
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.
“Some of the most horrific sights I’ve ever seen kept playing over and over, but when I started using NightWare, they stopped,” says Guithues. “In the morning, the device will tell me it’s intervened 25 or 30 times through the night, and I never woke up once. It’s to the point where I don’t remember any of the old nightmares.”
65 patients and NO statistically significant changes???? Both the sham and treated group did better???? But a "post-hoc" analysis said it works great!!!!
What a scam.
https://jcsm.aasm.org/doi/epdf/10.5664/jcsm.10338
Results: Both groups demonstrated statistically significant within-person improvement on all measures. While the Active system was generally associated with stronger magnitude of improvement, none of the comparisons of individual measures across conditions reached statistical significance. However, a post hoc analysis excluding participants with low frequency usage demonstrated significantly better improvement in perceived sleep quality with the Active device than Sham.
More:
https://www.fda.gov/news-events/press-announcements/fda-perm...
Throughout the night, Apple Watch sensors monitor body movement and heart rate during sleep. These data are sent to the Nightware server and, using a proprietary algorithm, the device creates a unique sleep profile for the patient. When Nightware detects that a patient is experiencing a nightmare based on its analysis of heart rate and body movement, the device provides vibrations through the Apple Watch while the product is in use.
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.