Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled study

Abstract

Background: Many patients with posttraumatic stress disorder (PTSD) suffer from sleep problems. Robot-based interventions might be an innovative approach to reduce sleep problems and hyperarousal in PTSD. However, the feasibility and effectiveness of a breath robot in patients with PTSD have never been empirically tested. The aim of this study is to investigate the feasibility of a breath robot to reduce sleep problems and hyperarousal in patients with PTSD. Methods: This randomized controlled feasibility study will include N = 30 adult patients with at least subsyndromal PTSD (PTSD Symptom Scale – Interview-5 (PSSI-5)) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) and impaired sleep quality (Pittsburgh Sleep Quality Index (PSQI) > 5). Patients with organic sleep disorders or currently in psychotherapeutic treatment are excluded. Study participants are randomized to receive either a 4-week Somnox 2 robot intervention including simulation of human breath or a 4-week Somnox 2 robot intervention without human breath simulation. The primary outcome will be the proportion of randomized participants providing outcome data at post-treatment. We consider a proportion of > 50% to indicate feasibility. Additional feasibility outcomes include eligibility rate, recruitment speed, uptake, retention, treatment adherence, and dropout. Potential outcomes of effectiveness (sleep quality, PSQI; severity of PTSD symptoms, PSSI-5) will be assessed at two time points, before (T0) and after (T1) the intervention. Sleep characteristics (Consensus Sleep Diary (CSD)) are measured daily. Discussion: This study is the first to investigate the feasibility of a novel breath robot intervention for reducing sleep problems and hyperarousal in PTSD patients, with effectiveness considered as a secondary outcome. If feasible and effective, the use of a breath robot could be a nonintrusive and flexible intervention to supplement psychotherapy or to bridge treatment gaps. Trial registration: DRKS, DRKS00031063. Registered on 10/012023.