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

Recruitingn/aAges 18 Years - anyAllZealand University Hospital
NCT06711159 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 br

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📋 Eligibility rules (as published)
Inclusion Criteria: For a subject to be eligible, all inclusion criteria must be answered "yes": 1. Age ≥18 years 2. Subjects must be diagnosed with Severe Obstructive Sleep Apnea (AHI \> 30) and have not yet started any form of PAP (positive airway pressure) treatment. 3. ESS score must be above 10 at the time of inclusion. Exclusion Criteria: For a subject to be eligible, all exclusion criteria must be answered "no": 1. Known severe neurological or psychiatric diseases. 2. Known congestive heart failure, chronic renal failure, liver failure, malignancy, severe pulmonary disease. 3. Considerable use of alcohol. 4. Medication judged by investigator to influence sleep/wake regulation to such a degree that data quality will be compromised. 5. Has cochlear implants. 6. Involved in therapies with medical devices that deliver electrical energy into the area around the implant. 7. Is at high risk of surgical complications, such as active systemic infection and haemorrhagic disease. 8. Are unable (i.e. mentally or physically impaired patient), or do not have the necessary assistance, to properly operate the device system. 9. Has an infection at the site of device implantation. 10. Operates MRI scanners. 11. 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. 12. 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). 13. Other known diseases or conditions, judged by investigator to influence sleep to such a degree that data quality will be compromised. 14. Incapable, judged by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation. 15. Pregnancy or intention to become pregnant within the next 12 months.
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What it tests

  • continuous positive airway pressure
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Where

1 site
Zealand University Hospital
Koege, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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