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

Sleep Clinical Trial

Official title: Sleep in the Ultra Long-Term Perspective: Seasonality and Behaviorally Induced Variation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Sleep

• NCT number: NCT04513743
• Study type: Interventional
• Source: UNEEG Medical A/S
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Completion date: July 4, 2022