Work package 6: Device and cloud-based software

Lead: Nox Medical

Nox Medical is an industrial leader in sleep diagnostic equipment. The Sleep Revolution works together with Nox Medical to provide and validate a new concept of multiple night home Self-Applied-Somnograph (SAS) studies instead of the current clinical gold standard; a complex single night in-lab Polysomnography (PSG). This opens for the possibility to transfer diagnostic procedure to the patient’s home. The current status of the SAS system is a research product that has not been released for clinical purpose. 

The optimal way to make the SAS technology available in scale for, both, researchers and clinical users is by designing the SAS technology as a medical device product, complying with all applicable standards and supported by clinical evidence. RU will perform 200 pilot studies in adults with a double setup of SAS and PSG for a single night to validate the use of the SAS in suspected SDB patients. The studies will include healthy sleepers, and those suspected with the most common sleep disorders: SDB, insomnia and periodic leg movements (PLM)/restless legs syndrome (RLS). 

Nox Medical will perform a transformation of signals and visualization for improving automated and manual scoring of the captured data. Based on manually scored data, the Noxturnal software will be modified to support better data capturing using the SAS system, including the supporting multiple night (three nights) of SAS scheduling and recording. Using the ISO13485 certified medical device development processes, the SAS will be redesigned as a medical device and first released with CE labelling in the EU. 

As is with every Medical Device development activity, the applicable process will include all the necessary steps to provide evidence of safety and efficiency requested for medical products, including risk analysis, usability testing, clinical evaluation, clinical validation and proper documentation for compliant Technical File. This will include all available and validated SAS accessories, software, and analysis at the time of implementation.

Participants: