NCT04513743

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: UNEEG Medical A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	24/7 EEG™ SubQ	24/7 EEG™ SubQ device will be worn by each subject for 365 nights

Timeline

• Start date: 2020-09-07
• Primary completion: 2022-06-20
• Completion: 2022-07-04
• First posted: 2020-08-14
• Last updated: 2023-12-08

Locations

1 site across 1 country: Denmark