ArticlePilot and feasibility studies2024
Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled study.
Article in Pilot and feasibility studies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Involvement of Matrix Metalloproteinases (MMP-2 and MMP-9), Inflammasome NLRP3, and Gamma-Aminobutyric Acid (GABA) Pathway in Cellular Mechanisms of Neuroinflammation in PTSD.International journal of molecular sciences · 2025Article
- LOTUS Software to Process Wearable EmbracePlus Data.Sensors (Basel, Switzerland) · 2024Article
- Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: A randomized controlled study.International journal of clinical and health psychology : IJCHPArticle
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
backgroundMany 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.
methodsThis 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 registrationDRKS, DRKS00031063. Registered on 10/012023.
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