A randomized, placebo-controlled trial using a novel PAP delivery platform to treat patients with OSA and comorbid PTSD

摘要

Purpose Positive airway pressure (PAP) adherence is poor in comorbid OSA/PTSD. SensAwake? (SA) is a wake-sensing PAP algorithm that lowers pressure when wake is detected. We compared auto-PAP (aPAP) with and without SA for comorbid OSA/ PTSD. Methods Prospective, randomized crossover study comparing aPAP to aPAP + SA. We enrolled patients with OSA/PTSD who were PAP naive. Four weeks after randomization, the patients were crossed over to the alternate treatment group, with final follow-up at eight weeks. Sleep questionnaires (ESS, ISI, FSS, and FOSQ-10) were assessed at baseline and follow-up. Results We enrolled 85 patients with OSA/PTSD. aPAP reduced AHI to < 5/h in both groups. Our primary endpoint, average hours of aPAP adherence (total) after 4 weeks, was significantly increased in the SA group in our intention-to-treat (ITT) analysis (beta= 1.13 (95% CI 0.16-2.1); p = 0.02), after adjustment for ESS differences at baseline. After adjustment for ESS, SA (ITT analysis) also showed significant improvement in percentage of nights used for >4h(beta= 14.9 (95% CI 1.02-28.9); p- 0.04). There were trends toward an increase in percentage nights used total (beta = 17.4 (95% CI - 0.1 to 34.9); p = 0.05), average hours of aPAP adherence (nights used) (beta = 1.04 (95% CI - 0.07 to 2.1);p = 0.07), and regular use (OR = 7.5 (95% CI 0.9-64.7); p = 0.07) after adjustment for ESS at baseline. After adjustment for ESS and days to cross over, SA by actual assignment did not show any effect on adherence variables. The ESS, ISI, FSS, and FOSQ-10 all showed significant improvements with PAP, but there were no differences in the magnitude of improvement in any score between groups. Conclusions Adherence to aPAP may be improved with the addition of SA and deserves further study. SA is as effective as standard aPAP for normalizing the AHI and improving sleep-related symptoms. Clinical trial registration ClinicalTrials.gov NCT02549508 https://clinicaltrials.gov/ct2/show/NCT02549508?term=NCT02549508&rank=1 "Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD".