Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513743
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2020-08-11
Brief Title:
Ultra Long-Term Sleep Monitoring Using UNEEG Medical 247 EEG SubQ
Sponsor:
UNEEG Medical AS
Organization:
UNEEG Medical AS
Study Overview
Official Title:
Sleep in the Ultra Long-Term Perspective Seasonality and Behaviorally Induced Variation
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ULTS
Brief Summary:
This study aims to evaluate the agreement between automated sleep analysis by UNEEG medicals 247 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 medicals 247 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 247 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
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 247 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None