Study aim:
This study aims to use a new brainwave monitoring device that meassure brainwaves 24 hours a day to create better understanding of sleep-wake interplay as a biomarker for excessive daytime sleepiness because of obstructive sleep apnea.
Study Method, Design, and Procedures Patients with sleep apnea referred to the Sleep Clinic at the Department of Ear, Nose, Throat, and Jaw Surgery in Køge for CPAP treatment, who also experience severe daytime sleepiness, will be offered participation in this study. The goal is for 15 participants to complete the entire protocol.
Procedure Overview Initial Sleep Assessment: The study begins with an in-depth sleep assessment through polysomnography (PSG) followed by a Multiple Sleep Latency Test (MSLT).
PSG: This sleep study evaluates sleep structure, confirms sleep apnea, and rules out other sleep disorders.
MSLT: This test measures the brain's tendency to fall asleep during the day. Additional Home-Based Sleep Studies: Participants will undergo two more PSG studies in their homes.
EEG Monitoring: After the initial assessments, participants will have a small EEG electrode implanted to monitor brain activity.
The implant, a CE-certified device called 24/7 EEG™ SubQ, will be inserted under local anesthesia by an experienced surgeon.
Once post-surgery swelling subsides (after about 7-10 days), continuous EEG monitoring will begin, where participants connect an external data storage device during the day. The device records for 12 weeks, and CPAP treatment begins around the 6-week mark.
After 12 weeks, the EEG device is removed, and the study ends. Aditional Data Collection (Optional)
During the 12 weeks of EEG recording, participants are asked to report:
Sleep Diary: Log daytime sleep episodes, including planned naps and unintended naps.
Questionnaires and Tests: Complete daily questionnaires about fatigue symptoms and perform a brief attention and reaction test. These tasks take 3-10 minutes each day and are accessible via smartphone or tablet.
Interviews and Movement Tracking: Participants may also be invited to interviews on how sleepiness affects their daily life and asked to wear a motion-tracking watch to monitor activity.
Age ≥18 years
Subjects must be diagnosed with Severe Obstructive Sleep Apnea (AHI > 30) and have not yet started any form of PAP (positive airway pressure) treatment.
ESS score must be above 10 at the time of inclusion.
Known severe neurological or psychiatric diseases.
Known congestive heart failure, chronic renal failure, liver failure, malignancy, severe pulmonary disease.
Considerable use of alcohol.
Medication judged by investigator to influence sleep/wake regulation to such a degree that data quality will be compromised.
Subjects eligible for this study are patients who suffer from Excessive Daytime Sleepiness (defined by an epworth sleepiness scale above 10 at inclussion) because of untreated Obstructive Sleep Apnoea (OSA) and with the inclusion/exclusion criteria listed below to ensure generalizability of study and to minimize the influence of other contributors to EDS.
Case-crossover
Prospective
continuous positive airway pressure
DeviceInitiation of treatment with continuous positive airway pressure for obstructive sleep apnea
Ultra long-term EEG derived sleepiness biomarker
Our primary explorative objective is to scrutinize subcutaneous Ultra Long-term EEG for potential biomarkers predicting sleepiness in OSA patients. Determining daytime wake-to-sleep transition rate, episodes of microsleep, and episodes of macro sleep, alongside the duration and patterns of these events. Our explorative findings will be correlated and preliminary validated against the well-established sleepiness metrics and questionnaires, multiple sleep latency test (MSLT), Epworth Sleepiness scale (ESS), Karolinska Sleepiness Scale (KSS), and a 3-minute psycomotor vigilance tast test (PVT), as well as to the patient's experience of falling asleep or dozing off intentionally and unintentionally in the form of a "sleep and nap diary". Any potential sleepiness biomarker derived from this study will be available for future confirmatory trials.
The effects of CPAP treatment on ultra long-term EEG
Our experimental objective is to determine the effects of CPAP treatment on sleep quality, quantity, and timing from the day-to-day perspective that ULT-EEG provides. Furthermore, the experimental design enables us to clinically validate the exploratively deduced sleepiness biomarker candidates through comparisons before and after the intervention of CPAP treatment conditions. Previous studies on the effect of CPAP on sleepiness reduction have shown a dose-dependent configuration with CPAP usage. ESS is typically reduced by 4,78 (or more). We expect relevant biomarker candidates to follow similar patterns when CPAP is introduced in a population with severe OSA and EDS.
Validate automatic sleep/wake classification from ultra long-term EEG for patients with severe obstructive sleep apnea
Our Secondary objective is to validate automatic sleep/wake classification based on two-channel subcutaneous EEG against golden standard manually scored polysomnography in patients with severe OSA. Additionally, we explore the use of Ecological Momentary Assessment (EMA) methods to record Excessive Daytime Sleepiness in OSA.
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