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Completed

NCT Number: NCT03586310

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.

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Key information

Conditions

Sleep Monitoring

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ear-EEG

Device

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

Primary outcomes

  1. Cohens kappa

    Time frame: At study completion (average of 6 months)

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Uneeg medical

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2018
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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