Exploring Brainwave Monitoring to Detect Daytime Sleepiness in Severe Obstructive Sleep Apnea Patients Using a 247 EEG Device and CPAP Treatment

What this Trial Is About

Researchers are exploring a new brainwave monitoring device to better understand the relationship between sleep and wakefulness as a marker for excessive daytime sleepiness in people with severe obstructive sleep apnea OSA. This study focuses on patients referred for CPAP treatment who experience severe daytime sleepiness, aiming to gather detailed brain activity data that may help identify sleepiness patterns and how CPAP treatment affects these patterns. Participants will undergo an initial in-depth sleep assessment using polysomnography PSG and a Multiple Sleep Latency Test MSLT to confirm sleep apnea and measure daytime sleepiness. Following these tests, a small EEG electrode device called 247 EEG SubQ will be implanted under local anesthesia to monitor brain activity continuously for 12 weeks. CPAP treatment will start around the 6-week point after implantation. Two additional home PSG studies will be performed during this period, and the EEG device will be removed at the end of the 12 weeks. Throughout the study, participants will keep a sleep diary, complete daily questionnaires about fatigue, and perform brief cognitive tests on a smartphone or tablet. They may also participate in interviews and wear a motion-tracking watch to monitor activity. Researchers will assess sleepiness using EEG data, sleepiness scales, and cognitive performance tests over approximately four months from enrollment to study completion, while monitoring safety and any adverse effects related to the implant and procedures.

SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnoea - An Explorative Study