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Dementia Associated Apathy.

Primary Purpose

Emotions, Dementia, Apathy

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Skin conductance and Heart rate measurement
Sponsored by
Zurich University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Emotions focused on measuring Dementia, Aphathy, Emotion, Images, Skin conductance, Heart rate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Zurich University of applied SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with dementia

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 21, 2017
Last Updated
July 12, 2018
Sponsor
Zurich University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03293537
Brief Title
Dementia Associated Apathy.
Official Title
Skin Conductance and Heart Rate as Biomarkers to Uncover Covert Emotional Reactions in Patients With Dementia Associated Apathy; a Multi-centre Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
July 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zurich University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotions, Dementia, Apathy
Keywords
Dementia, Aphathy, Emotion, Images, Skin conductance, Heart rate

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with dementia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Skin conductance and Heart rate measurement
Intervention Description
while observing selected photos the Skin conductance and heart rate will be measured.
Primary Outcome Measure Information:
Title
Skin conductance
Description
The change in skin conductance will be taken to be the peak amplitude of the change in skin conductance
Time Frame
15 minutes
Title
Heart rate
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silke Neumann, MSc
Phone
0041 58 934 49 76
Email
neus@zhaw.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidrun Becker, Prof.DR.
Organizational Affiliation
Zurich University of Applied Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Zurich University of applied Sciences
City
Winterthur
State/Province
Thurgau
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silke Neumann, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Dementia Associated Apathy.

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