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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Monitoring

Intervention / Treatment
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* Device: ear-EEG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained and letter of authority signed before any study related activities Age 18-50 years - Exclusion Criteria: BMI (body mass index) > 30 Previous stroke or cerebral haemorrhage and any other structural cerebral disease Known or suspected abuse of alcohol or any other neuro-active substance Use of hearing aid or cochlear implants Allergic contact dermatitis caused by metals or generally prone to skin irritation Narrow or malformed ear canals Obstructive sleep apnea History of sleep disorders or neurological diseases Chronic pain People judged incapable, by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation. Use of medication known to influence the user's sleep (antidepressants, sedatives, antipsychotic-, and pain relieving medication) Teeth grinding (bruxism) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 4 nights with PSG<br>For all subjects: 4 nights with polysomnography and ear-EEG | Device: ear-EEG<br>* soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.<br>|
| Other: 12 nights with ear-EEG<br>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<br>* soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.<br>|

What is the study measuring?
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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) |