Healthy SubjectsNCT05111847

Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part I

A study testing Short-term Baseplates first then long-term Baseplates and Long-term Baseplates first then short-term Baseplates in people with Healthy Subjects, run by UNEEG Medical A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this clinical investigation is to test the safety and performance of short- and longterm Baseplates constructed with different types of biocompatible adhesives. Read more about this study

Who is it for?: Ages 18 to 120 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Short-term Baseplates first then long-term Baseplates and Long-term Baseplates first then short-term Baseplates
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteDenmark
Study dates: 12 Oct 2021to 23 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 120 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Informed consent obtained, and letter of authority signed before any study related activities
Are at least 18 years of age and have full legal capacity
Healthy skin behind the ear

Who cannot join

Pregnant or breastfeeding
Known allergic responses to the adhesives
Treatment with corticosteroids, either as a cream in the area behind the ear or systemically (tablet or injection) within the last month
Subject is unable or does not have the necessary assistance to properly operate the device system

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital
København NV, 2400

Other trials in Denmark

About this study

Official title: Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder- Part I

The purpose of this clinical investigation is to test the safety and performance of short- and longterm Baseplates constructed with different types of biocompatible adhesives.

Read the detailed description

This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S

Conditions: Healthy Subjects
Being tested: Short-term Baseplates first then long-term Baseplates, Long-term Baseplates first then short-term Baseplates

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Short-term Baseplates first then long-term BaseplatesDevice
Short-term Baseplates A and B tested for 17/18 days first then long-term Baseplates C and D tested for 17/18 days
Long-term Baseplates first then short-term BaseplatesDevice
Long-term Baseplates C and D tested for 17/18 days first then short-term Baseplates A and B tested for 17/18 days

Study groups in NCT05111847
Study group	Role	What they receive
Short-term Baseplates first then long-term Baseplates	Other	Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone Receives: Device: Short-term Baseplates first then long-term Baseplates
Long-term Baseplates first then short-term Baseplates	Other	Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel Receives: Device: Long-term Baseplates first then short-term Baseplates

What is being measured

The primary outcome is the main question the study is designed to answer.

Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness
To evaluate the skin barrier functionality (i.e., skin-friendliness) after repeated use of Baseplates (i.e., adhesives) on the skin behind the ear.
High levels of TEWL reflects unhealthy skin, i.e. high loss of water that passes from inside a body through the epidermis.
Measured: 17-18 days

Secondary outcomes (1)

Skin Reactions
Systematic assessment (visual inspection by investigator and self-reporting by participant via daily questionnaires). Some skin reactions were also reported as adverse device effects (see Adverse Event section)
Measured: 17-18 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 202123 Jun 2022

First posted8 Nov 2021
Study start12 Oct 2021
Primary completion23 Jun 2022
Study completion23 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy SubjectsStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: In Part I of the study, the baseplates type A, B, C and D were tested on the skin behind the ears. Each subject tested either 1) short-term baseplates A and B first for 17/18 days and then long-term baseplates C and D for 17/18 days or 2) long-term baseplates C and D first for 17/18 days and then short-term baseplates A and B for 17/18 days.
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05111847
Sponsor's protocol ID: U009 Part I
Status last verified: Dec 2025
First submitted: 7 Oct 2021
Last updated: 14 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder- Part I
ClinicalTrials.gov ID: NCT05111847
Acronym / sponsor ID: U009 Part I
Conditions: Healthy Subjects
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: UNEEG Medical A/SIndustry (pharma, biotech, devices)
Study start: 12 Oct 2021 (actual)
Primary completion: 23 Jun 2022 (actual)
Study completion: 23 Jun 2022 (actual)
First posted: 8 Nov 2021 (actual)
Results: Posted 14 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this clinical investigation is to test the safety and performance of short- and longterm Baseplates constructed with different types of biocompatible adhesives.

Detailed description

This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: In Part I of the study, the baseplates type A, B, C and D were tested on the skin behind the ears. Each subject tested either 1) short-term baseplates A and B first for 17/18 days and then long-term baseplates C and D for 17/18 days or 2) long-term baseplates C and D first for 17/18 days and then short-term baseplates A and B for 17/18 days.

Arm	Type	Receives
Short-term Baseplates first then long-term Baseplates	Other	Device: Short-term Baseplates first then long-term BaseplatesShort-term Baseplates - Type A: Acrylate Type B: YUKI-gel Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone
Long-term Baseplates first then short-term Baseplates	Other	Device: Long-term Baseplates first then short-term BaseplatesLong-term Baseplates - Type C: Hydrocolloid Type D: Silicone Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Informed consent obtained, and letter of authority signed before any study related activities
Are at least 18 years of age and have full legal capacity
Healthy skin behind the ear

Key exclusion criteria (4 listed)

Pregnant or breastfeeding
Known allergic responses to the adhesives
Treatment with corticosteroids, either as a cream in the area behind the ear or systemically (tablet or injection) within the last month
Subject is unable or does not have the necessary assistance to properly operate the device system

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
Short-term Baseplates first then long-term BaseplatesShort-term Baseplates A and B tested for 17/18 days first then long-term Baseplates C and D tested for 17/18 days	Device	Short-term Baseplates first then long-term Baseplates
Long-term Baseplates first then short-term BaseplatesLong-term Baseplates C and D tested for 17/18 days first then short-term Baseplates A and B tested for 17/18 days	Device	Long-term Baseplates first then short-term Baseplates

Primary outcome

Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness
Time frame: 17-18 days
To evaluate the skin barrier functionality (i.e., skin-friendliness) after repeated use of Baseplates (i.e., adhesives) on the skin behind the ear. High levels of TEWL reflects unhealthy skin, i.e. high loss of water that passes from inside a body through the epidermis.

1 secondary outcome

Skin Reactions
Time frame: 17-18 days

Results and safety

Results posted to the registry on 14 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Short-term Baseplates First, Then Long-term Baseplates	16	15
Long-term Baseplates First, Then Short-term Baseplates	17	16

Primary outcome: Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness

Time frame: 17-18 days. Mean (Standard Deviation). Unit: g/m²/h

Measure	Short-term Baseplate Type A: Acrylate n = 32	Short-term Baseplate Type B: YUKI-gel n = 32	Long-term Baseplate Type C: Hydrocolloid n = 33	Long-term Baseplate Type D: Sillicone n = 33
Test area	20.7 (11.1)	8.0 (2.4)	19.3 (8.0)	8.0 (3.0)
Control area	7.5 (2.1)	7.3 (1.8)	7.5 (1.8)	7.1 (2.3)

Population analysed: Participants with at least one TEWL measurement following use of the given baseplate type

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Short-term Baseplate Type A: Acrylic	0 of 32 (0%)	22 of 32 (68.8%)	0 of 32
Short-term Baseplate Type B: Yuki-gel	0 of 32 (0%)	15 of 32 (46.9%)	0 of 32
Long-term Baseplate Type C: Hydrocolloid	0 of 33 (0%)	29 of 33 (87.9%)	0 of 33
Long-term Baseplate Type D: Silicone	0 of 33 (0%)	26 of 33 (78.8%)	0 of 33

Limitations and caveats (from the sponsor): The study did not have a formal power and sample size calculation. Some skin reactions were reported both as an ADE and separately in the "skin reaction questionnaire". When recording objective skin measurements, particularly TEWL, it is important that the room conditions, such as temperature and humidity, which may have affected the skin measurements. However, all TEWL measurements were within acceptable range.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Tonny Karlsmark, Dr. study chair

Bispebjerg Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 14 Jan 2026. 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?

Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness (time frame: 17-18 days). 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 NCT05111847.

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 14 Jan 2026.