EmotionsNCT03293537
Dementia Associated Apathy.
A study testing Skin conductance and Heart rate measurement in people with Emotions and Dementia, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Skin conductance and Heart rate measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Oct 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Zurich University of applied Sciences
Winterthur, Thurgau
Silke Neumann, MSc
About this study
Official title: Skin Conductance and Heart Rate as Biomarkers to Uncover Covert Emotional Reactions in Patients With Dementia Associated Apathy; a Multi-centre Study.
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.
- Being tested
- Skin conductance and Heart rate measurement
- Keywords
- Dementia, Aphathy, Emotion, Images, Skin conductance, Heart rate
- Medical subject headings
- Dementia, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin conductance and Heart rate measurementDiagnostic test
while observing selected photos the Skin conductance and heart rate will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Patients with dementia | Experimental | 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. Receives: Diagnostic Test: Skin conductance and Heart rate measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin conductance
The change in skin conductance will be taken to be the peak amplitude of the change in skin conductance
Measured: 15 minutes
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.
Measured: 15minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start30 Oct 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silke Neumann, Zurich University of Applied Sciences
- Investigators
- Heidrun Becker, Prof.DR., Study chair, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293537
- Sponsor's protocol ID
- Biomarker and Apathy
- Status last verified
- Jul 2018
- First submitted
- 21 Sep 2017
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Conductance and Heart Rate as Biomarkers to Uncover Covert Emotional Reactions in Patients With Dementia Associated Apathy; a Multi-centre Study.
- ClinicalTrials.gov ID
- NCT03293537
- Acronym / sponsor ID
- Biomarker and Apathy
- Keywords
- Dementia, Aphathy, Emotion, Images, Skin conductance, Heart rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with dementia | Experimental | Diagnostic Test: Skin conductance and Heart rate measurementThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Known or suspected non-compliance, drug or alcohol abuse,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin conductance and Heart rate measurementwhile observing selected photos the Skin conductance and heart rate will be measured. | Diagnostic test | Patients with dementia |
Primary outcome
Skin conductance
Time frame: 15 minutes
The change in skin conductance will be taken to be the peak amplitude of the change in skin conductance
Heart rate
Time frame: 15minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidrun Becker, Prof.DR. study chair
Zurich University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin conductance and Heart rate measurement in people with Emotions and Dementia, run by Zurich University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silke Neumann, MSc (0041 58 934 49 76, neus@zhaw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin conductance (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018; AzTrials last refreshed its copy on 27 Oct 2026.