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

UNEEG medical

Status

Completed

Conditions

Sleep

Treatments

Diagnostic Test: 24/7 EEG™ SubQ

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04513743

U003

Details and patient eligibility

About

This study aims 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) from healthy subjects.

Full description

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.