N/A N=33 Randomized Basic Science

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

Healthy Subjects

Bottom Line

View on ClinicalTrials.gov: NCT05111847 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2026

Primary outcome: Primary: Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness — 20.7; 8.0; 19.3; 8.0 g/m²/h

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Short-term Baseplates first then long-term Baseplates (Device); Long-term Baseplates first then short-term Baseplates (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UNEEG Medical A/S
Primary completion: Jun 2022

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	—

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.

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

View full record on ClinicalTrials.gov →

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.