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ID
Bron
Verkorte titel
Synoniemen aandoening
Aandoening
stress systeem
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Om de MASQUE-wearable te valideren voor stressdetectie bij gezonde oudere
volwassenen, worden de prestaties van de MASQUE-wearable vergeleken met de
Eda4Move 4 (het referentieapparaat [RD]) tijdens rust en stressinducerende
taken.
Secundaire uitkomstmaten
We vergelijken de nauwkeurigheid van het detecteren van stress van onze
MASQUE-wearable met ervaren stress en emotionele reacties (zelfrapportage).
Secundaire uitkomsten omvatten ook het draagcomfort van het sensorsysteem en
het vermogen van MASQUE om pijn te meten (dit laatste is een verkennende
uitkomst).
Achtergrond van het onderzoek
People with dementia and people with an intellectual disability (ID) are
vulnerable to stress. If stress build-up goes unnoticed, it can lead to
challenging behavior. This has a negative impact on the quality of life of
people with dementia, people with an ID and their caregivers. Together with
people with dementia, people with a mild ID, and their family and professional
caregivers, we have developed a sensor system in clothing that is able to
recognize stress build-up at an early stage. This sensor system - MASQUE - is
incorporated into a sock. The sensors use the sweat response of the body, skin
conductance, as a measure of stress. When MASQUE recognizes a build-up in
stress, it notifies the (family) caregiver (or person with dementia or person
with ID) so that they can respond accordingly.
The sensor system has already been validated in healthy adults and tested in
people with ID. However, skin conductance may change with medication use and
increasing age. Therefore, it is important to validate MASQUE in older adults.
Validation of the sensor system is necessary for safe use in long-term care
organizations in the future, and thereby reducing challenging behavior and
improving quality of life for people with dementia and people with an ID.
Doel van het onderzoek
To validate the garment-integrated sensor system (MASQUE) to detect stress in
healthy older adults (65+). Secondary objectives are to assess wearer*s comfort
of MASQUE and to explore the possibility of the MASQUE in detecting pain.
Onderzoeksopzet
In this study, participants perform a number of stress-inducing tasks
alternated by moments of rest in a controlled environment (laboratory setting)
. The participant will wear the MASQUE-wearable and a validated wearable. The
validated wearable is used as 'golden standard' to compare MASQUE with. Before
and after each stress-inducing task, participants report about the stress
experienced at that moment (subjective/ self-report measure). Self-report data
will be compared with the data from the wearables to see if the MASQUE wearable
can detect stress. To measure pain, we will use two validated pain inducing
tasks. Participants will also complete a self-report questionnaire about
perceived pain and stress during these pain tasks.
Onderzoeksproduct en/of interventie
Participants will wear our garment-integrated sensor system MASQUE on their
foot and the other validated stress-detecting wearable around their ankle
during a battery of stress inducing, rest (baseline), and two pain tasks in a
2-hour laboratory session.
Inschatting van belasting en risico
Participation in the study includes a one-time 120-minute laboratory session
during which the participant wears two stress-sensing wearables (MASQUE and
reference). Participants are asked to perform various stress-inducing tasks,
both psychological (e.g. arithmetic task) and physical stress (e.g. hot/cold
test). In addition, participants are asked to complete questionnaires about,
among other things, perceived stress. We use validated stress and pain tasks
with minimal to no risks for the participants. The participant can stop the
task at any time without giving a reason. Each task takes a few minutes at
most. There are moments of rest between the stress tasks. The researcher will
regularly check with the participant whether everything is going well and
whether they want to move on to the next task.
Participants themselves have no direct benefit from participating in this
study. However, participation does help to validate the sensor system, which
can be used to detect stress build-up at an early stage in people with dementia
and people with an intellectual disability. The system can be used to decrease
stress and prevent challenging behavior thereby contributing to a better
quality of life for people with dementia and people with an intellectual
disability in long-term care.
There are no known risks from other studies for the reference wearable (EdaMove
4).
The MASQUE wearable is worn for a short time (about 2 hours) and is comparable
to a regular sock. During the lab session, we examine the wearer's comfort. The
Senti module (sends the signal to the platform to read the data from the
knowing response; part of HUME) is clicked on top of the sock. When worn for
longer periods of time, this may feel a little uncomfortable.
Publiek
Hippocratespad 21
Leiden 2300 RC
NL
Wetenschappelijk
Hippocratespad 21
Leiden 2300 RC
NL
Landen waar het onderzoek wordt uitgevoerd
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded
from participation:
- Physical disease, such as cardio-vascular instability, or current mental
disorder such as depression, anxiety disorder, schizophrenia, or alcohol or
drug dependency/abuse
- Medication use that interferes with sweat production system (anticholinergic
medication) or heart rate (Beta- or Calcium blocking).
- Medical use of compression stockings.
- Muscle or neurodegenerative disease (Parkinson, dementia, etc.)
Medication use and co-morbidity will be discussed with the trial-physician.
Opzet
Deelname
In onderzoek gebruikte producten en hulpmiddelen
metc-ldd@lumc.nl
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Register | ID |
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CCMO | NL85963.058.24 |