Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ
NCT ID: NCT04513743
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2020-09-07
2022-07-04
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Healthy adults
UNEEG™ medical 24/7 EEG™ SubQ
24/7 EEG™ SubQ
24/7 EEG™ SubQ device will be worn by each subject for 365 nights
Interventions
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24/7 EEG™ SubQ
24/7 EEG™ SubQ device will be worn by each subject for 365 nights
Eligibility Criteria
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Inclusion Criteria
* Subjects must be of general good health
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Zealand University Hospital
OTHER
Cambridge Cognition Ltd
INDUSTRY
UNEEG Medical A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Troels W Kjær, Professor
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital
Locations
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Zealand University Hospital
Roskilde, , Denmark
Countries
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References
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Ahrens E, Jennum P, Duun-Henriksen J, Djurhuus B, Homoe P, Kjaer TW, Hemmsen MC. Automatic sleep staging based on 24/7 EEG SubQ (UNEEG medical) data displays strong agreement with polysomnography in healthy adults. Sleep Health. 2024 Dec;10(6):612-620. doi: 10.1016/j.sleh.2024.08.007. Epub 2024 Oct 15.
Other Identifiers
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U003
Identifier Type: -
Identifier Source: org_study_id