Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ

The aim of the study is to evaluate the agreement between automated sleep analysis by UNEEG medical's 24/7 EEG™ SubQ device using a deep learning algorithm and the consensus score of multiple sleep technologists' manual scoring of 120 gold-standard polysomnograms (PSG).

The study will enroll 20 healthy subjects who will wear the UNEEG™ SubQ device for 365 consecutive nights. All subjects are prescreened and invited to an interview to confirm eligibility. Subjects who provide informed consent are enrolled and will complete a detailed demographic, medical, health, sleep, and lifestyle survey. The enrolled subjects will have the UNEEG™ SubQ implanted and after approximately 10 days of healing the study subjects will start wearing the external part of the 24/7 EEG™ SubQ. Throughout the study the subjects will wear an ActiGraph, fill out a sleep diary and conduct cognitive tests. The duration of the study from screening to removal of sutures will be approximately 58 weeks.

Inclusion criteria

• Age ≥18 years
• Subjects must be of general good health

Exclusion criteria

• 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 hemorrhagic 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). N.B.: diving/snorkeling is allowed to 5 meters 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).
• Previous stroke or cerebral hemorrhage and any other structural cerebral disease.
• Ongoing or history of sleep disorders.
• Known neurological diseases.
• Known or suspected abuse of alcohol defined as estimated consumption beyond that, which is recommended by the Danish Health Authority or any other neuro-active substances.
• Other known diseases or conditions, judged by investigator to influence sleep to such a degree that data quality will be compromised.
• Medication 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.