Usability and Performance Assessment of DormoTech VLAB

The intended use of the V-Lab device is to serve as Type 2 Sleep test, an inexpensive, more comfortable device that can replace the full sleep study in a sleep lab and at-home environment.

The device is composed of three units, two of which are wearable and the third is a central unit responsible for communication; The head unit is worn on the face like a mask, and the body unit is a belt that is worn around the torso. After a few minutes of wearing the device, the patient will become ignorant of its presence. A small rechargeable 3V Li-ion battery operates both units.

The V-Lab system supports the connectivity of peripheral devices for capturing additional signals using Bluetooth technology, e.g. pulse oximeters. The V-Lab device collects and stores physiological signals such as EEG, EOG, EMG, Total Airflow, Snore, Respiratory Effort (Thoracic and Abdominal), Body and Head Position, and HR (derived from Plethysmography) Both the head and chest units communicate with the central units via Bluetooth, and the wearable units send the measured data to the central unit. The central unit receives the data, stores it within an internal flash drive, and transmits it via Wi-Fi to online servers for further diagnosis.

Using the recorded data, a physician can diagnose sleep disorders manually or use any sleep diagnostic system that supports EDF Formats.

The study Objectives are to assess the efficiency, usability, durability, safety, and patient satisfaction of the V-Lab device and to validate the level of agreement between the V-Lab device and a PSG.