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

Launched by ZEALAND UNIVERSITY HOSPITAL · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial, called SLEEPINESS, is looking to better understand why some people with severe obstructive sleep apnea (OSA) feel very sleepy during the day. The researchers are using a special device that monitors brainwaves around the clock to find out how sleep and wakefulness interact in these patients. They are recruiting individuals who have been diagnosed with severe OSA and have not yet started treatment. Eligible participants must be at least 18 years old and have a certain level of daytime sleepiness.

If you join the study, you will undergo a series of sleep assessments and have a small device implanted under your skin to continuously monitor your brain activity for 12 weeks. You’ll also keep a daily sleep diary, complete short questionnaires about how tired you feel, and possibly wear a motion-tracking watch. Throughout the study, you’ll start using a CPAP machine, which helps you breathe better during sleep, around the sixth week. This study is not only about gathering data but also about potentially improving treatment options for those struggling with excessive daytime sleepiness due to sleep apnea.

Gender

ALL

Eligibility criteria

• 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.