No abstract

ZusammenfassungDie Atemfrequenz ist ein wichtiger Risikomarker, mit dessen Hilfe kritisch kranke und gefährdete Patienten im klinischen Alltag frühzeitig erkannt werden können. Ziel dieser Pilotstudie an 31 Patienten der COPD-Schweregrade II – IV war es, die mittlere nächtliche Atemfrequenz anhand von Atemgeräuschaufnahmen zu bestimmen und die Abhängigkeit der Atemfrequenz von COPD-Schweregrad und Raucherstatus zu untersuchen. Die mittlere Atemfrequenz (AF) des Gesamtkollektivs betrug 19/min. Bei den COPD-GOLD-Schweregraden konnten keine signifikanten Unterschiede hinsichtlich der mittleren Atemfrequenz ermittelt werden. Unter Berücksichtigung des Nikotinkonsums zeigte sich bei den aktiven Rauchern eine signifikant höhere mittlere AF von 20,84 ± 4,45/min im Vergleich zu den Nichtrauchern mit 17,41 ± 3,14/min (p < 0,05). Zudem gehörten aktive Raucher in der Studie signifikant häufiger zur Gruppe der Patienten mit nächtlichem Wheezing (60 % vs. 23,8 %). Dies könnte dafür sprechen, dass Raucher eine erhöhte Atemarbeit mit erhöhter Atemfrequenz zur Kompensation des Sauerstoffmangels bei bronchialer Obstruktion leisten müssen. Die Ergebnisse der vorliegenden Studie zeigen, dass mit der akustischen Aufzeichnung der Atemgeräusche eine verlässliche Darstellung und Berechnung der Atemfrequenz möglich ist.

!Background: Respiratory flow detection with the aim of detecting sleep-related breathing disorders plays a major role in polysomnography. Due to the fact that pneumotachographs are too bulky and not suitable for measurements during sleep, the ThorAKUSTIK system has been developed. By attaching a noise sensor right next to larynx, it determines the respiratory flow in an acoustic way. Methods: The ThorAKUSTIK system as well as a pneumotachograph were applied simultaneously. The correlation between those two methods has been calculated. Patients: We investigated twenty male subjects. All of them were non-smokers. Results: The ThorAKUSTIK-System showed a highly positive correlation (r = 0.89 to 0.91; p < 0.01) and was able to measure the respiratory flow in a reliable way. Conclusions: The ThorAKUSTIK-System allows a long-term live monitoring and has the potential to be used in several clinical departments. Larger studies are necessary to verify the application in the clinical routine.

The increasing use of mobile digital technologies in our daily life is also affecting the healthcare sector. Digital health applications have the potential to improve disease monitoring and management, avoid hospitalizations, and more. A main task for the health care system is to create a framework that facilitates the identification of safe and effective apps for health care professionals and patients to generate the most health benefit as well as guide payer coverage decisions. Currently some European countries have already developed a national framework for market access approval, nevertheless only Belgium and Germany have additionally created a reimbursement system. The aim of this investigation is to compare the two different approaches of Belgium and Germany, based on the framework itself, the access requirements, and the experience so far. The overall approach seems to be similar, but scrutinizing the details, there are several significant differences. The evaluation procedure in Belgium consists of a 3-level validation pyramid while in Germany there is a normal procedure as well as a DiGA-Fast- Track. Only applications in stage 3 are reimbursable in Belgium whereas in Germany applications from provisional and permanent listing are reimbursable. The comparative overview shows that the two forerunners, Belgium, and Germany, use similar but not identical approaches, with partly relevant differences such as the evaluation procedure reimbursement and the formulation of the target group. The current situation (status 11.04.22) shows that the focus of the app indications differs between both countries. Furthermore, not a single app is listed in Belgium and Germany at the same time. From our perspective it should be a goal for manufacturers of CE marked medical devices to achieve reimbursement in as many member states as possible.

Stress is a major influence on the quality of life in our fast-moving society. This paper describes a standardized and contemporary protocol that is capable of inducing moderate psychological stress in a laboratory setting. Furthermore, it evaluates its effects on physiological biomarkers. The protocol called “THM-Stresstest” mainly consists of a rest period (30 min), an app-based stress test under the surveillance of an audience (4 min) and a regeneration period (32 min). We investigated 12 subjects to evaluate the developed protocol. We could show significant changes in heart rate variability, electromyography, electro dermal activity and salivary cortisol and α-amylase. From this data we conclude that the THM-Stresstest can serve as a psychobiological tool for provoking responses in the cardiovascular-, the endocrine and exocrine system as well as the sympathetic part of the central nervous system.