Trial Outcomes & Findings for Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part I (NCT NCT05111847)

Last Updated: 2026-01-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

17-18 days

Results posted on

2026-01-14

Participant Flow

One subject was enrolled by mistake (and signed informed consent) but was immediately excluded. The subject was enrolled despite having a high degree of dandruff and thus did not have healthy skin as required per the inclusion criteria. This subject was not randomized and did not provide any data.

Unit of analysis: Head sides

Participant milestones

Participant milestones
Measure	Short-term Baseplates First, Then Long-term Baseplates Started with 1-day use adhesives for 17-18 days: Type A: Acrylate behind one ear and Type B: YUKI-gel behind the other ear. Subsequently tested 4-days use adhesives for 17-18 days: Type C: Hydrocolloid behind one ear and Type D: Silicone behind the other ear	Long-term Baseplates First, Then Short-term Baseplates Started with 4-days use adhesives for 17-18 days: Type C: Hydrocolloid behind one ear and Type D: Silicone behind the other ear. Subsequently tested 1-day use adhesives for 17-18 days: Type A: Acrylate behind one ear and Type B: YUKI-gel behind the other ear.
First intervention (17-18 days) STARTED	16 32	17 34
First intervention (17-18 days) COMPLETED	15 30	16 32
First intervention (17-18 days) NOT COMPLETED	1 2	1 2
Second intervention (17-18 days) STARTED	15 30	16 32
Second intervention (17-18 days) COMPLETED	14 28	16 32
Second intervention (17-18 days) NOT COMPLETED	1 2	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

All enrolled participants in compliance with in- and exclusion criteria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Short-term Baseplates First, Then Long-term Baseplates n=32 Head sides Started with 1-day use adhesives for 17-18 days: Type A: Acrylate behind one ear and Type B: YUKI-gel behind the other ear. Subsequently tested 4-days use adhesives for 17-18 days: Type C: Hydrocolloid behind one ear and Type D: Silicone behind the other ear	Long-term Baseplates First, Then Short-term Baseplates n=34 Head sides Started with 4-days use adhesives for 17-18 days: Type C: Hydrocolloid behind one ear and Type D: Silicone behind the other ear. Subsequently tested 1-day use adhesives for 17-18 days: Type A: Acrylate behind one ear and Type B: YUKI-gel behind the other ear.	Total n=66 Head sides Total of all reporting groups
Sex: Female, Male Female	7 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	11 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	18 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Age, Continuous	24.5 years n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	45 years n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	32 years n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Sex: Female, Male Male	9 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	6 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	15 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	0 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	2 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	17 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	29 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	0 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	2 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	0 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	1 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Race (NIH/OMB) Asian	1 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	1 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	2 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	0 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	0 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Race (NIH/OMB) Black or African American	0 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	0 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	0 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Race (NIH/OMB) White	10 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	16 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	26 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Race (NIH/OMB) More than one race	2 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	0 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	2 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=14 Participants • All enrolled participants in compliance with in- and exclusion criteria	0 Participants n=10 Participants • All enrolled participants in compliance with in- and exclusion criteria	2 Participants n=24 Participants • All enrolled participants in compliance with in- and exclusion criteria

PRIMARY outcome

Timeframe: 17-18 days

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

Outcome measures

Outcome measures
Measure	Short-term Baseplate Type A: Acrylate n=32 Head sides Short-term Baseplate type A tested behind one ear for 17-18 days	Short-term Baseplate Type B: YUKI-gel n=32 Head sides Short-term Baseplate type B tested behind one ear for 17-18 days	Long-term Baseplate Type C: Hydrocolloid n=33 Head sides Long-term Baseplate type C tested behind one ear for 17-18 days	Long-term Baseplate Type D: Sillicone n=33 Head sides Long-term Baseplate type D tested behind one ear for 17-18 days
Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness Test area	20.7 g/m²/h Standard Deviation 11.1	8.0 g/m²/h Standard Deviation 2.4	19.3 g/m²/h Standard Deviation 8.0	8.0 g/m²/h Standard Deviation 3.0
Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness Control area	7.5 g/m²/h Standard Deviation 2.1	7.3 g/m²/h Standard Deviation 1.8	7.5 g/m²/h Standard Deviation 1.8	7.1 g/m²/h Standard Deviation 2.3

SECONDARY outcome

Timeframe: 17-18 days

Population: Participants with at least one skin assessment after use of the given Baseplate type

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)

Outcome measures

Outcome measures
Measure	Short-term Baseplate Type A: Acrylate n=32 Head sides Short-term Baseplate type A tested behind one ear for 17-18 days	Short-term Baseplate Type B: YUKI-gel n=32 Head sides Short-term Baseplate type B tested behind one ear for 17-18 days	Long-term Baseplate Type C: Hydrocolloid n=33 Head sides Long-term Baseplate type C tested behind one ear for 17-18 days	Long-term Baseplate Type D: Sillicone n=33 Head sides Long-term Baseplate type D tested behind one ear for 17-18 days
Skin Reactions	24 Head sides	15 Head sides	29 Head sides	26 Head sides

Adverse Events

Short-term Baseplate Type A: Acrylic

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Short-term Baseplate Type B: Yuki-gel

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Long-term Baseplate Type C: Hydrocolloid

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Long-term Baseplate Type D: Silicone

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Short-term Baseplate Type A: Acrylic n=32 participants at risk Short-term Baseplate type A tested behind one ear for 17-18 days	Short-term Baseplate Type B: Yuki-gel n=32 participants at risk Short-term Baseplate type B tested behind one ear for 17-18 days	Long-term Baseplate Type C: Hydrocolloid n=33 participants at risk Long-term Baseplate type C tested behind one ear for 17-18 days	Long-term Baseplate Type D: Silicone n=33 participants at risk Long-term Baseplate type D tested behind one ear for 17-18 days
Skin and subcutaneous tissue disorders Skin reaction	68.8% 22/32 • From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days. Adverse device effects (ADEs) were categorized according to International Medical Device Regulators Forum (IMDRF). Skin reactions reported by visual inspection and daily questionnaires were also collected as a secondary endpoint separate from adverse event registration (see Outcome Measures).	43.8% 14/32 • From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days. Adverse device effects (ADEs) were categorized according to International Medical Device Regulators Forum (IMDRF). Skin reactions reported by visual inspection and daily questionnaires were also collected as a secondary endpoint separate from adverse event registration (see Outcome Measures).	87.9% 29/33 • From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days. Adverse device effects (ADEs) were categorized according to International Medical Device Regulators Forum (IMDRF). Skin reactions reported by visual inspection and daily questionnaires were also collected as a secondary endpoint separate from adverse event registration (see Outcome Measures).	78.8% 26/33 • From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days. Adverse device effects (ADEs) were categorized according to International Medical Device Regulators Forum (IMDRF). Skin reactions reported by visual inspection and daily questionnaires were also collected as a secondary endpoint separate from adverse event registration (see Outcome Measures).
General disorders Discomfort, pain, headache	3.1% 1/32 • From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days. Adverse device effects (ADEs) were categorized according to International Medical Device Regulators Forum (IMDRF). Skin reactions reported by visual inspection and daily questionnaires were also collected as a secondary endpoint separate from adverse event registration (see Outcome Measures).	3.1% 1/32 • From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days. Adverse device effects (ADEs) were categorized according to International Medical Device Regulators Forum (IMDRF). Skin reactions reported by visual inspection and daily questionnaires were also collected as a secondary endpoint separate from adverse event registration (see Outcome Measures).	0.00% 0/33 • From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days. Adverse device effects (ADEs) were categorized according to International Medical Device Regulators Forum (IMDRF). Skin reactions reported by visual inspection and daily questionnaires were also collected as a secondary endpoint separate from adverse event registration (see Outcome Measures).	3.0% 1/33 • From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days. Adverse device effects (ADEs) were categorized according to International Medical Device Regulators Forum (IMDRF). Skin reactions reported by visual inspection and daily questionnaires were also collected as a secondary endpoint separate from adverse event registration (see Outcome Measures).

Additional Information

Clinical Operations, Medical Affairs

UNEEG medical

Phone: +45 41414244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place