Evaluation of the Ear-EEG System for Sleep Monitoring in Healthy Subjects
NCT ID: NCT03586310
Last Updated: 2020-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-03-23
2020-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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4 nights with PSG
For all subjects: 4 nights with polysomnography and ear-EEG
ear-EEG
soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.
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.
ear-EEG
soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.
Interventions
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ear-EEG
soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.
Eligibility Criteria
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Inclusion Criteria
Age 18-50 years
\-
Exclusion Criteria
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
18 Years
50 Years
ALL
Yes
Sponsors
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Uneeg medical
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Preben Kidmose, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Aarhus University
Aarhus, , Denmark
Countries
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Other Identifiers
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EarEEGSleep2018
Identifier Type: -
Identifier Source: org_study_id