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

Recruiting now

Conditions studied: Obstructive Sleep Apnea (OSA), Excessive Daytime Sleepiness

In brief

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.

Key facts

Study ID

NCT06711159

Run by

Zealand University Hospital

People needed

15

Starts

2024-10-11

Expected to finish

2025-12-31

Last updated by the study team

2024-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For a subject to be eligible, all inclusion criteria must be answered "yes":
• 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.

You may not qualify if…

• For a subject to be eligible, all exclusion criteria must be answered "no":
• 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.
• Has cochlear implants.
• Involved in therapies with medical devices that deliver electrical energy into the area around the implant.
• Is at high risk of surgical complications, such as active systemic infection and haemorrhagic disease.
• Are unable (i.e. mentally or physically impaired patient), or do not have the necessary assistance, to properly operate the device system.
• Has an infection at the site of device implantation.
• Operates MRI scanners.
• Has a profession/hobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). NB: diving/snorkelling is allowed to 5 metres depth.
• Has a profession/hobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing).
• Other known diseases or conditions, judged by investigator to influence sleep to such a degree that data quality will be compromised.
• Incapable, judged by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
• Pregnancy or intention to become pregnant within the next 12 months.

Where it is running

• Zealand University Hospital — Koege, Regional Zealand, Denmark (enrolling)

Full record on ClinicalTrials.gov

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