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

Sleep Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586310
• Other study ID #: EarEEGSleep2018
• Status: Completed
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: November 9, 2020

Study information

• Verified date: May 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 9, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Monitoring

Intervention

Device:
• ear-EEG
soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Uneeg medical

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)