SleepULTSNCT04513743
Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ
A study testing 24/7 EEG™ SubQ in people with Sleep, run by UNEEG Medical A/S at 1 site in Denmark.
Trial summary
This study aims to evaluate the agreement between automated sleep analysis by UNEEG medical's 24/7 EEG™ SubQ device using a deep learning algorithm and the consensus score of multiple sleep technologists' manual scoring of 120 gold-standard polysomnograms (PSG) from healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- 24/7 EEG™ SubQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Sep 2020to 4 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Subjects must be of general good health
Who cannot join
- Has cochlear implants.
- Involved in therapies with medical devices that deliver electrical energy into the area around the implant
- Is at high risk of surgical complications, such as active systemic infection and hemorrhagic disease.
- Are unable (i.e. mentally or physically impaired patient), or do not have the necessary assistance, to properly operate the device system.
- Has an infection at the site of device implantation.
- Operates MRI scanners.
Show all 16Show fewer
- Has a profession/hobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). N.B.: diving/snorkeling is allowed to 5 meters depth.
- Has a profession/hobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing).
- Previous stroke or cerebral hemorrhage and any other structural cerebral disease.
- Ongoing or history of sleep disorders.
- Known neurological diseases.
- Known or suspected abuse of alcohol defined as estimated consumption beyond that, which is recommended by the Danish Health Authority or any other neuro-active substances.
- Other known diseases or conditions, judged by investigator to influence sleep to such a degree that data quality will be compromised.
- Medication judged by investigator to influence sleep to such a degree that data quality will be compromised.
- Incapable, judged by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
- Pregnancy or intention to become pregnant within the next 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep in the Ultra Long-Term Perspective: Seasonality and Behaviorally Induced Variation
This study aims to evaluate the agreement between automated sleep analysis by UNEEG medical's 24/7 EEG™ SubQ device using a deep learning algorithm and the consensus score of multiple sleep technologists' manual scoring of 120 gold-standard polysomnograms (PSG) from healthy subjects.
Read the detailed description
The aim of the study is to evaluate the agreement between automated sleep analysis by UNEEG medical's 24/7 EEG™ SubQ device using a deep learning algorithm and the consensus score of multiple sleep technologists' manual scoring of 120 gold-standard polysomnograms (PSG).
The study will enroll 20 healthy subjects who will wear the UNEEG™ SubQ device for 365 consecutive nights. All subjects are prescreened and invited to an interview to confirm eligibility. Subjects who provide informed consent are enrolled and will complete a detailed demographic, medical, health, sleep, and lifestyle survey. The enrolled subjects will have the UNEEG™ SubQ implanted and after approximately 10 days of healing the study subjects will start wearing the external part of the 24/7 EEG™ SubQ. Throughout the study the subjects will wear an ActiGraph, fill out a sleep diary and conduct cognitive tests. The duration of the study from screening to removal of sutures will be approximately 58 weeks.
- Conditions
- Sleep
- Being tested
- 24/7 EEG™ SubQ
- Keywords
- Circadian, Chronobiology, Sleep quality, Automated sleep staging, Implantable device
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24/7 EEG™ SubQDiagnostic test
24/7 EEG™ SubQ device will be worn by each subject for 365 nights
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Experimental | UNEEG™ medical 24/7 EEG™ SubQ Receives: Diagnostic Test: 24/7 EEG™ SubQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep stage agreement
Automatically determined sleep stages using data from 24/7 EEG SubQ, sleep stages manually determined according to the American Academy of Sleep Medicine (AASM) manual using the PSG recordings. The goal is to evaluate the performance of classification of AASM sleep stages at each 30-sec epoch determined automatically from the data recorded using the 24/7 EEG SubQ, to those determined by the consensus score (most prevalent score) of the sleep technologists' scoring of each subject's PSG record from the same night.
Measured: 1 year
Secondary outcomes (2)
Quantitative sleep parameters agreement
The quantitative sleep parameters recommended by the AASM manual. The goal is to evaluate the agreement between automatically determined clinically relevant parameters using data recorded from the 24/7 EEG SubQ and to those determined by the consensus score (most prevalent score) of the sleep technologists' scoring of each subject's PSG record from the same night.
Measured: 1 year
Non-Inferiority in sleep/wake monitoring
Automatically determined sleep/wake epochs using data from 24/7 EEG SubQ, automatically determined sleep/wake epochs using ActiLife 6 and data from ActiGraph Link GT9X, sleep/wake epochs manually determined according to the AASM manual using the PSG recordings. The goal is to show non-inferiority of sleep/wake monitoring using 24/7 EEG SubQ in a head-to-head comparison with actigraphy using PSG as a reference and gold standard.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start7 Sep 2020
- Primary completion20 Jun 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNEEG Medical A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zealand University Hospital, Cambridge Cognition Ltd
- Responsible party
- Sponsor
- Investigators
- Troels W Kjær, Professor, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513743
- Sponsor's protocol ID
- U003
- Acronym
- ULTS
- Status last verified
- Dec 2023
- First submitted
- 11 Aug 2020
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahrens E, Jennum P, Duun-Henriksen J, Djurhuus B, Homoe P, Kjaer TW, Hemmsen MC. Automatic sleep staging based on 24/7 EEG SubQ (UNEEG medical) data displays strong agreement with polysomnography in healthy adults. Sleep Health. 2024 Dec;10(6):612-620. doi: 10.1016/j.sleh.2024.08.007. Epub 2024 Oct 15.
PubMed 39406630
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep in the Ultra Long-Term Perspective: Seasonality and Behaviorally Induced Variation
- ClinicalTrials.gov ID
- NCT04513743
- Acronym / sponsor ID
- ULTS / U003
- Conditions
- Sleep
- Keywords
- Circadian, Chronobiology, Sleep quality, Automated sleep staging, Implantable device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- UNEEG Medical A/SIndustry (pharma, biotech, devices)
- Collaborators
- Zealand University Hospital, Cambridge Cognition Ltd
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 14 Aug 2020 (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.
This study aims to evaluate the agreement between automated sleep analysis by UNEEG medical's 24/7 EEG™ SubQ device using a deep learning algorithm and the consensus score of multiple sleep technologists' manual scoring of 120 gold-standard polysomnograms (PSG) from healthy subjects.
Detailed description
The aim of the study is to evaluate the agreement between automated sleep analysis by UNEEG medical's 24/7 EEG™ SubQ device using a deep learning algorithm and the consensus score of multiple sleep technologists' manual scoring of 120 gold-standard polysomnograms (PSG).
The study will enroll 20 healthy subjects who will wear the UNEEG™ SubQ device for 365 consecutive nights. All subjects are prescreened and invited to an interview to confirm eligibility. Subjects who provide informed consent are enrolled and will complete a detailed demographic, medical, health, sleep, and lifestyle survey. The enrolled subjects will have the UNEEG™ SubQ implanted and after approximately 10 days of healing the study subjects will start wearing the external part of the 24/7 EEG™ SubQ. Throughout the study the subjects will wear an ActiGraph, fill out a sleep diary and conduct cognitive tests. The duration of the study from screening to removal of sutures will be approximately 58 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | Experimental | Diagnostic Test: 24/7 EEG™ SubQUNEEG™ medical 24/7 EEG™ SubQ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Subjects must be of general good health
Key exclusion criteria (16 listed)
- Has cochlear implants.
- Involved in therapies with medical devices that deliver electrical energy into the area around the implant
- Is at high risk of surgical complications, such as active systemic infection and hemorrhagic disease.
- Are unable (i.e. mentally or physically impaired patient), or do not have the necessary assistance, to properly operate the device system.
- Has an infection at the site of device implantation.
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 |
|---|---|---|
| 24/7 EEG™ SubQ24/7 EEG™ SubQ device will be worn by each subject for 365 nights | Diagnostic test | Healthy adults |
Primary outcome
Sleep stage agreement
Time frame: 1 year
Automatically determined sleep stages using data from 24/7 EEG SubQ, sleep stages manually determined according to the American Academy of Sleep Medicine (AASM) manual using the PSG recordings. The goal is to evaluate the performance of classification of AASM sleep stages at each 30-sec epoch determined automatically from the data recorded using the 24/7 EEG SubQ, to those determined by the consensus score (most prevalent score) of the sleep technologists' scoring of each subject's PSG record from the same night.
2 secondary outcomes
Quantitative sleep parameters agreement
Time frame: 1 year
Non-Inferiority in sleep/wake monitoring
Time frame: 1 year
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 8 Dec 2023.
- Derived from this study: PubMed 39406630Ahrens E, Jennum P, Duun-Henriksen J, Djurhuus B, Homoe P, Kjaer TW, Hemmsen MC. Automatic sleep staging based on 24/7 EEG SubQ (UNEEG medical) data displays strong agreement with polysomnography in healthy adults. Sleep Health. 2024 Dec;10(6):612-620. doi: 10.1016/j.sleh.2024.08.007. Epub 2024 Oct 15.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
Troels W Kjær, Professor principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24/7 EEG™ SubQ in people with Sleep, run by UNEEG Medical A/S 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 2 inclusion and 16 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 8 Dec 2023. 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?
Sleep stage agreement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04513743, which also lists 1 linked publication.
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 8 Dec 2023.