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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Diagnostic test: 24/7 EEG™ SubQ

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥18 years
• Subjects must be of general good health

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy adults; UNEEG™ medical 24/7 EEG™ SubQ	Diagnostic test: 24/7 EEG™ SubQ; 24/7 EEG™ SubQ device will be worn by each subject for 365 nights

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep stage agreement	Automatically determined sleep stages using data from 24/7 EEG SubQ, sleep stages manually determined according to the American Academy of Sleep Medicine (AASM) manual using the PSG recordings. The goal is to evaluate the performance of classification of AASM sleep stages at each 30-sec epoch determined automatically from the data recorded using the 24/7 EEG SubQ, to those determined by the consensus score (most prevalent score) of the sleep technologists' scoring of each subject's PSG record from the same night.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative sleep parameters agreement	The quantitative sleep parameters recommended by the AASM manual. The goal is to evaluate the agreement between automatically determined clinically relevant parameters using data recorded from the 24/7 EEG SubQ and to those determined by the consensus score (most prevalent score) of the sleep technologists' scoring of each subject's PSG record from the same night.	1 year
Non-Inferiority in sleep/wake monitoring	Automatically determined sleep/wake epochs using data from 24/7 EEG SubQ, automatically determined sleep/wake epochs using ActiLife 6 and data from ActiGraph Link GT9X, sleep/wake epochs manually determined according to the AASM manual using the PSG recordings. The goal is to show non-inferiority of sleep/wake monitoring using 24/7 EEG SubQ in a head-to-head comparison with actigraphy using PSG as a reference and gold standard.	1 year

Collaborators and Investigators

• Sponsor: UNEEG Medical A/S
• Collaborators: Zealand University Hospital; Cambridge Cognition Ltd
• Investigators: Principal Investigator: Troels W Kjær, Professor, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): July 4, 2022

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Sleep quality; Chronobiology; Circadian; Automated sleep staging; Implantable device
• Other Study ID Numbers: U003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No