NCT04513743

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

September 7, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2022

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

August 11, 2020

Last Update Submit

December 7, 2023

Conditions

Sleep

Keywords

CircadianChronobiologySleep qualityAutomated sleep stagingImplantable device

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Quantitative sleep parameters agreement

    1 year

  • Non-Inferiority in sleep/wake monitoring

    1 year

Study Arms (1)

Healthy adults

EXPERIMENTAL

UNEEG™ medical 24/7 EEG™ SubQ

Diagnostic Test: 24/7 EEG™ SubQ

Interventions

24/7 EEG™ SubQDIAGNOSTIC_TEST

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

Healthy adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 39406630DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Troels W Kjær, Professor

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 14, 2020

Study Start

September 7, 2020

Primary Completion

June 20, 2022

Study Completion

July 4, 2022

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)