Evaluation of the Ear-EEG System for Sleep Monitoring in Healthy Subjects

Subjects sleep multiple nights in their own home, wearing actigraph, PSG (PolySomnoGraphy) and ear-EEG sensors. The object of the study is to determine the applicability of ear-EEG for sleep monitoring.

Study Overview

• Status: Completed
• Conditions: Sleep Monitoring
• Intervention / Treatment: Device: ear-EEG

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Informed consent obtained and letter of authority signed before any study related activities

Age 18-50 years

-

Exclusion Criteria:

1. BMI (body mass index) > 30
2. Previous stroke or cerebral haemorrhage and any other structural cerebral disease
3. Known or suspected abuse of alcohol or any other neuro-active substance
4. Use of hearing aid or cochlear implants
5. Allergic contact dermatitis caused by metals or generally prone to skin irritation
6. Narrow or malformed ear canals
7. Obstructive sleep apnea
8. History of sleep disorders or neurological diseases
9. Chronic pain
10. People judged incapable, by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
11. Use of medication known to influence the user's sleep (antidepressants, sedatives, antipsychotic-, and pain relieving medication)
12. Teeth grinding (bruxism)
13. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 4 nights with PSG; For all subjects: 4 nights with polysomnography and ear-EEG	Device: ear-EEG; soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.
Other: 12 nights with ear-EEG; For a subset of the subjects in arm the '4 nights with PSG', a second phase follows in which each subject sleeps 12 nights with only ear-EEG. If a night's recording is unsuccessful, for whatever reason, up to 6 additional nights may be attempted.	Device: ear-EEG; soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohens kappa	The test outcome is a set of matched polysomnography and ear-EEG sleep measurements. From this will be generated an algorithm for automatic sleep scoring based on ear-EEG (using leave-one-subject-out cross validation). The primary outcome measure of the test is the correlation between the automatically generated hypnograms and those generated manually from the scalp recordings. The accuracy is quantified using Cohen's kappa, which is a number between -1 and 1. An average (across all recordings) above 0.4 would be a success for the test. As the training of the sleep scoring algorithm requires large amounts of data, it is necessary to use a large number of subjects (20) to estimate the viability of automatic sleep scoring from ear-EEG recordings. This also means that kappa values are calculated for all recordings at once when the measurements are done. This method for creating sleep scoring algorithms and quantifying their success is in line with standard procedure in this field.	At study completion (average of 6 months)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Uneeg medical
• Investigators: Principal Investigator: Preben Kidmose, Professor, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2018
• Primary Completion (Actual): November 9, 2020
• Study Completion (Actual): November 9, 2020

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: EarEEGSleep2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of results, anonymized recordings will be made available to the scientific community.
• IPD Sharing Time Frame: We anticipate that data will be made available at some point in 2019.

Drug and device information, study documents

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