CClinicalTrials.gg
Status unknownNCT03293537Updated Jul 16, 2018

Dementia Associated Apathy.

An interventional study of Skin conductance and Heart rate measurement in Emotions, Dementia and Apathy, sponsored by Zurich University of Applied Sciences. Status unknown at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2018-07-16.

Sponsored by Zurich University of Applied Sciences · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
133
Allocation
Not applicable
Sex
All
01

Study summary

We want to determine if patients with dementia show any kind of emotion while they look at a defined selection of photos. These are photos taken from a international image-platform and mixed with photos (biographic) that show personal objects, personal events, etc.

While the photos will be presented each a few seconds the skin conductance and the heart rate will be measured. We want to find out if there is any emotion measurable while showing the photos.

Read the detailed description

The lack of overt behaviour in individuals exhibiting dementia-associated apathy is not only stressful to family members and caregivers, it is also a major challenge for medical and nursing staff. Knowing whether apathy arises from an impaired function of the neural network of affect due to neurodegenerative processes accompanying dementia provides a neural explanation of this condition. Somatic indicators of affective responses (e.g., changes in skin conductance, or heart rate) are an effective means to uncover covert emotional responses in nursing home residents suffering from dementia associated apathy.

The overall objective is to determine whether dementia associated apathy is the result of an impaired functioning of the neural macro-network of affect. We want to compare the quantitative change in physiological parameters for each image category between individuals of the two subgroups: 1. Individual with dementia only and 2.individuals with dementia and dementia-associated apathy.

The primary objective is to uncover a covert emotional response using changes in skin conductance in patients with dementia and patients with dementia + dementia associated apathy.

The secondary objective is to uncover a covert emotional response using changes in the heart rate in patients with dementia and patients with dementia + dementia associated apathy.

Diagnosis of dementia, age at initial dementia diagnosis, age at initial apathy diagnosis, time since initial diagnosis of dementia and apathy will be obtained from medical records. The type and daily dose of medication as well as the type and frequency of occupational, physio- and psychosocial therapy will be drawn from medical records. The SMMSE (Severe Mini Mental State Examination)score will determine severity of dementia and the AES (Apathy Evaluation Scale )score the severity of apathy. Using the FAST (Functional Assessment Staging) will assess the capacity of performing the activities of daily life.

Measurements will be conducted in a familiar environment and in the presence of a family member or a member of staff to avoid any kind of stress and concern for the participant. The subject will be informed of the procedure and their task before the sensors are attached. Electrodermal activity (EDA) and heart rate (HR) will be continuously monitored while the subject views the image sequence on a PC monitor. EDA and HR will be recorded concurrently using commercial software. Data analysis will involve both commercial and in-house software. All data will be stored on a hard disk, in a compressed and encrypted format.

02

Conditions studied

  • Emotions
  • Dementia
  • Apathy

Browse trials for

Keywords

  • Dementia
  • Aphathy
  • Emotion
  • Images
  • Skin conductance
  • Heart rate
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • existing medical diagnosis of dementia, independent of the presence or absence of neuropsychiatric symptoms.

We include nursing home residents with Informed Consent as documented by signature from the German speaking part of Switzerland with moderate to severe dementia.

The presence or absence of apathy serves to assign participants into the appropriate experiments group.

Exclusion criteria

Exclusion Criteria:

  • Known or suspected non-compliance, drug or alcohol abuse,

    • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders
    • Previous enrolment into the current study,
    • Enrolment of the investigator, his/her family members, employees and other dependent persons,
    • Medically documented diagnosis of schizophrenia or bipolar disorder or the diagnosis of diminished intelligence.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
133 participants (estimated)

Study arms

  • Experimental
    Patients with dementia

    The subject will be informed of the procedure and their task before the sensors are attached. Electrodermal activity (EDA) and heart rate (HR) will be continuously monitored while the subject views the image sequence on a PC monitor. EDA will be measured using electrodes attached to the middle (D3) and ring finger (D4). Heart rate will be measured using an infrared pulseoximeter attached to one of the free digits of the hand. A pulseoximeter is a non-invasive sensor, using tissue absorption of infrared light to determine blood-oxygen saturation (SaO2). EDA and HR will be recorded concurrently using commercial software. Data analysis will involve both commercial and in-house software.

    Diagnostic Test: Skin conductance and Heart rate measurement

Interventions

  • Diagnostic testSkin conductance and Heart rate measurement

    while observing selected photos the Skin conductance and heart rate will be measured.

05

What researchers measure

Primary outcomes

  1. Skin conductance

    The change in skin conductance will be taken to be the peak amplitude of the change in skin conductance

    Time frame: 15 minutes

  2. Heart rate

    The heart rate measured in Hertz (HZ). The Heart rate will be measured using an infrared pulseoximeter attached to one of the free digits of the hand.

    Time frame: 15minutes

06

Study locations

1 of 1 sites recruiting
  • Zurich University of applied Sciences
    Winterthur, Thurgau, Switzerland
    • Silke Neumann, MSc · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03293537
Lead sponsor
Zurich University of Applied Sciences
Responsible party
Silke Neumann (MSc, Zurich University of Applied Sciences) — Principal investigator
First posted
Sep 26, 2017
Start date
Oct 30, 2017
Primary completion
Dec 31, 2018 (estimated)
Completion
Jul 31, 2019 (estimated)
Last update
Jul 16, 2018

Study contacts

Silke Neumann, MSc
Contact
neus@zhaw.ch
0041 58 934 49 76
Heidrun Becker, Prof.DR.
study chair · Zurich University of Applied Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion