Status:
COMPLETED
Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ
Lead Sponsor:
UNEEG Medical A/S
Collaborating Sponsors:
Zealand University Hospital
Cambridge Cognition Ltd
Conditions:
Sleep
Eligibility:
All Genders
18+ years
Phase:
NA
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 technologi...
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 te...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Subjects must be of general good health
Exclusion
- 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.
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04513743
Start Date
September 7 2020
End Date
July 4 2022
Last Update
December 8 2023
Active Locations (1)
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1
Zealand University Hospital
Roskilde, Denmark, 4000