Clinical trial NCT04513743: Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ
Official title: Sleep in the Ultra Long-Term Perspective: Seasonality and Behaviorally Induced Variation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Circadian
Chronobiology
Sleep quality
Automated sleep staging
Implantable device
Lead sponsor: UNEEG Medical A/S
Sponsor class: INDUSTRY
Collaborators: name: Zealand University Hospital
name: Cambridge Cognition Ltd
First posted: 2020-08-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep stage agreement
timeFrame: 1 year
Secondary outcomes:
measure: Quantitative sleep parameters agreement
timeFrame: 1 year
measure: Non-Inferiority in sleep/wake monitoring
timeFrame: 1 year
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital
name: Troels W Kjær, Professor
role: PRINCIPAL_INVESTIGATOR
References: