N/A
Completed N=33
Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part I
Healthy Subjects
Source: ClinicalTrials.gov NCT05111847 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness — 20.7; 8.0; 19.3; 8.0 g/m²/h
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness |
20.7; 8.0; 19.3; 8.0; 7.5; 7.3 | — |
| SECONDARY Skin Reactions |
24; 15; 29; 26 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05111847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.