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

University of Aarhus

Status: Completed

Conditions: Sleep Monitoring

Treatments: Device: ear-EEG

Study type: Interventional

Funder types: Other

Identifiers

NCT03586310

EarEEGSleep2018

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

4 nights with PSG

Other group

Description:

For all subjects: 4 nights with polysomnography and ear-EEG

Treatment:

Device: ear-EEG

12 nights with ear-EEG

Other group

Description:

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.

Treatment:

Device: ear-EEG