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

Condition(s) studied

Investigational drug(s) / intervention(s)

continuous positive airway pressure: Initiation of treatment with continuous positive airway pressure for obstructive sleep apnea

Study summary

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.

Eligibility

Primary outcome measure(s)

• Ultra long-term EEG derived sleepiness biomarker — From enrollment to completion 4 months
  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 — From enrollment to completion 4 months
  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.

Trial sites (1)

More Zealand University Hospital trials in Denmark

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