Real-world reduction in nightmare frequency and distress among San Francisco first responders treated with a prescription wearable device: a 60-day open-label pilot.

OBJECTIVE: Nightmares are a common, distressing condition among individuals with post-traumatic stress disorder (PTSD) and are associated with impaired sleep quality and elevated suicide risk. First responders carry a substantial burden of occupational trauma and PTSD yet are under-represented in nightmare-treatment research. NightWare is an FDA-authorized prescription wearable that monitors heart rate and movement during sleep and delivers vibrotactile feedback intended to interrupt nightmares and improve sleep quality. We evaluated the real-world response to NightWare among San Francisco first responders. METHODS: First responders (law enforcement and fire service) prescribed NightWare in routine clinical care completed structured self-report assessments at Day 0, 30, and 60. First responders were aged 35-65, half were male and half were female. They had a PTSD diagnosis and at least 3 nightmares per week. The co-primary endpoints were nightmare frequency (self-reported nights with nightmares per week, 0-7) and nightmare-related distress (5-point ordinal scale, 0-4). Change was assessed with paired t-tests (with Cohen's d) and one-way repeated-measures analysis of variance (RM-ANOVA). RESULTS: Of 11 first responders who initiated treatment, 10 (91%) completed all assessments. Mean nightmare frequency decreased from 5.2 to 3.6 nights/week [mean change -1.6; 95% CI -2.7 to -0.5; t (9) = -3.21, p = 0.011; d = 1.0] and mean distress decreased from 2.9 to 1.3 [mean change -1.6; 95% CI -2.2 to -1.0; t (9) = -6.00, p = 0.0002; d = 1.9]. RM-ANOVA confirmed a significant decline across the three time points for both endpoints (frequency p = 0.009; distress p = 0.003). Seven of ten reduced nightmare frequency and nine of ten improved on distress; no participant worsened on either measure. Self-reported sleep quality and treatment satisfaction improved. The participants in this survey used the NightWare device a mean of 76% of nights (45.6 days of the 60-day survey time period). The range of usage was 55-100% (33-60 days) of the study nights. CONCLUSIONS: In this small, open-label, real-world pilot, treatment with NightWare was associated with clinically meaningful reductions in nightmare frequency and distress and high patient acceptability among first responders. These findings are hypothesis-generating; controlled studies with validated instruments are warranted.