NCT03293537

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

September 21, 2017

Last Update Submit

July 12, 2018

Conditions

EmotionsDementiaApathy

Keywords

DementiaAphathyEmotionImagesSkin conductanceHeart rate

Outcome Measures

Primary Outcomes (2)

  • Skin conductance

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

    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.

    15minutes

Study Arms (1)

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.

Diagnostic Test: Skin conductance and Heart rate measurement

Interventions

Skin conductance and Heart rate measurementDIAGNOSTIC_TEST

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

Patients with dementia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zurich University of applied Sciences

Winterthur, Thurgau, Switzerland

RECRUITING

MeSH Terms

Conditions

DementiaLethargy

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Heidrun Becker, Prof.DR.

    Zurich University of Applied Sciences

    STUDY CHAIR

Central Study Contacts

Silke Neumann, MSc

CONTACT

0041 58 934 49 76neus@zhaw.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

September 21, 2017

First Posted

September 26, 2017

Study Start

October 30, 2017

Primary Completion

December 31, 2018

Study Completion

July 31, 2019

Last Updated

July 16, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)