stress regulation system stress response
Conditions
Interventions
Participants will wear our garment-integrated sensor system MASQUE on one foot and the other validated stress-detecting wearable around their ankle on their other foot during a battery of stress induc
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - >= 65 years of age - Participant is able to walk for 5 minutes - Participant can fill in questionnaires in Dutch- Participant is in good healthAmendment:For the additional measurements with the new-and-improved sock:The inclusion criteria are the same. If recruitment within this target group proves insufficient, additional healthy volunteers aged 18 and older may be included to ensure the desired number of inclusions is reached within the data collection period for the study. This additional inclusion does not alter the research procedures, tasks or burden for participants. For the sub-study for the left vs. right comparison, the age criterion will be 18 years of age and older. We aim to include a broad age range for this sub-study.
Exclusion criteria
Exclusion criteria: Physical disease that could interfere with or hinder proper EDA measurement and/or the execution of tasks, such as cardio-vascular instability, or current mental disorder(s) such as depression, anxiety disorder, schizophrenia, or alcohol or drug dependency/abuse. Medical conditions or diseases that interfere with safe participation in the socially evaluated cold-pressor test (SECPT; specifically submerging hands in ice water), such as circulatory disorders (e.g. Raynaud syndrome), or diabetes mellitus.Medication use that interferes with or hinder proper EDA measurement and/or execution of tasks (e.g. anticholinergic medication, Beta- or Calcium blocking).Use of pacemaker or implantable cardioverter-defibrillator (ICD).Medical use of compression stockings, or oily cremes.Muscle or neurodegenerative disease (Parkinson, dementia, etc.).Fever (>38.5°C) on the day of the assessment.Medication use and co-morbidity will be discussed with the trial-physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To validate the MASQUE-wearable for stress detection in healthy older adults, the performance of the MASQUE-wearable is compared with the Eda4Move 4 (reference device [RD]) during baseline measurements and stress-inducing tasks. | — |
Secondary
| Measure | Time frame |
|---|---|
| We compare the stress detecting accuracy of our MASQUE-wearable with experienced stress and emotional response (self-report). Secondary outcomes also include the wearer comfort of the sensor system and the ability of MASQUE to measure pain (the latter is an exploratory outcome). For the sub-study, we examine whether difference exists between the left and right feet for the stress parameters (based on EDA). | — |
Countries
Netherlands
Contacts
Public ContactHJA Smaling
Leids Universitair Medisch Centrum
Outcome results
None listed