Sleep MonitoringNCT03586310
Evaluation of the Ear-EEG System for Sleep Monitoring in Healthy Subjects
A study testing ear-EEG in people with Sleep Monitoring, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Monitoring
- What is being tested?
- ear-EEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Mar 2018to 9 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent obtained and letter of authority signed before any study related activities
- Age 18-50 years
- -
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sleep Monitoring
- Being tested
- ear-EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ear-EEGDevice
soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.
| Study group | Role | What they receive |
|---|---|---|
| 4 nights with PSG | Other | For all subjects: 4 nights with polysomnography and ear-EEG Receives: Device: ear-EEG |
| 12 nights with ear-EEG | Other | 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. Receives: Device: ear-EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study completion (average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start23 Mar 2018
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep MonitoringStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Uneeg medical
- Responsible party
- Sponsor
- Investigators
- Preben Kidmose, Professor, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586310
- Sponsor's protocol ID
- EarEEGSleep2018
- Status last verified
- May 2019
- First submitted
- 16 Mar 2018
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of results, anonymized recordings will be made available to the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ear-EEG System for Sleep Monitoring in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03586310
- Acronym / sponsor ID
- EarEEGSleep2018
- Conditions
- Sleep Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Uneeg medical
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 nights with PSG | Other | Device: ear-EEGFor all subjects: 4 nights with polysomnography and ear-EEG |
| 12 nights with ear-EEG | Other | Device: ear-EEGFor 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Informed consent obtained and letter of authority signed before any study related activities
- Age 18-50 years
- -
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ear-EEGsoft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier. | Device | 12 nights with ear-EEG, 4 nights with PSG |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: Yes. After publication of results, anonymized recordings will be made available to the scientific community.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preben Kidmose, Professor principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ear-EEG in people with Sleep Monitoring, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohens kappa (time frame: At study completion (average of 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.