Evaluation of the Viability of Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging in Comparison With Polysomnography

What this Trial Is About

Researchers are evaluating the use of combined wearable and portable devices for sleep staging, comparing their results with standard polysomnography to achieve clinical and diagnostic validation. The study focuses on three types of devices: movement sensors (actigraphy), wearable EEG bands, and smartphones. This observational study involves healthy participants and those with sleep disorders, aiming to assess the accuracy of these technologies for sleep monitoring. The study is conducted in two stages. In the first stage, combinations of actigraphy and wearable EEG bands will be tested on 48 healthy volunteers aged 20 to 80 years without sleep disorders. Participants will undergo overnight polysomnography while simultaneously using the device combinations. In the second stage, the most effective combination from stage one will be tested on 60 participants aged 20 to 80 years who have at least one sleep disorder or complaint, including insomnia, sleep apnea risk, or excessive sleepiness. All participants will undergo the same procedures. Participants will visit a sleep lab for a full night of type-1 polysomnography conducted according to recommended standards, while also wearing the study devices. Researchers will measure various sleep parameters immediately after polysomnography, including sleep latency, total sleep time, sleep efficiency, wake after sleep onset, latency to REM sleep, and the time and percentage of each sleep stage. The study will monitor these outcomes to evaluate the diagnostic validity of the wearable and portable devices compared to polysomnography.

Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging