Validation of the NeuroTec Loft
Primary Purpose
Neurodegenerative Diseases, Activities of Daily Living, Aging
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Monitoring by unobtrusive sensors
Sponsored by
About this trial
This is an interventional prevention trial for Neurodegenerative Diseases
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Aged ≥18 years
- German speaking
Exclusion Criteria:
- Infected by multidrug-resistant bacteria according to current medical history
- Incontinence
Sites / Locations
- ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental_Arm
Arm Description
Assessment of behavior during day and night by unobtrusive sensors
Outcomes
Primary Outcome Measures
Heart rate (Vital parameters)
The heart rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Respiration rate (Vital parameters)
The respiration rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Oxygen saturation (Vital parameters)
The oxygen saturation will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Systolic / Diastolic blood pressure (Vital parameters)
The blood pressure will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Skin conductance (Vital parameters)
The skin conductance will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Secondary Outcome Measures
3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
The pose will be assessed continuously by pressure sensors, radar sensors, accelerometer, gyroscope, motion tracking (gold standard), lidar sensors, piir sensors.
Full Information
NCT ID
NCT04793555
First Posted
March 3, 2021
Last Updated
August 10, 2022
Sponsor
University of Bern
Collaborators
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT04793555
Brief Title
Validation of the NeuroTec Loft
Official Title
Validation of an Apartment to Monitor Human Behaviour During Day and Night
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
Insel Gruppe AG, University Hospital Bern
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
The progression of neurodegenerative disorders and the increasing number of elderly people intensifies the need of institutional care, which contrasts with the desire of most elderly and patients to live independently at home. The rapid evolution of assistive technology offers new possibilities in providing medical professionals preventive services in real-time. Therefore, the main focus of this study is on the individual sensors and how they can be combined to one unobtrusive system to assess the human behaviour and daily activities during day and night in an instrumented apartment in healthy participants.
Detailed Description
The higher prevalence of age-associated neurodegenerative disorders (e.g. Parkinson, Alzheimer), is in line with a steady increase of the average life expectancy in Switzerland. With the progression of neurodegenerative disorders and the increasing number of elderly people, the need for institutional care intensifies, which contrasts with the desire of most elderly and patients to live independently. The rapid evolution of assistive technology offers new possibilities in providing medical professionals preventive services in real-time. An extended stay in the hospital could influence independent ageing negatively and thus, monitoring has great potential to prevent critical events. In this study, the main focus is on the individual sensors and how they can be combined to one unobtrusive system. In addition, to get an understanding which parameters of the sensors are important and how the data can be extracted and processed (algorithms). Therefore, the aim of this study is to validate the accuracy to assess human behaviour and daily activities during day and night by unobtrusive sensors in an instrumented apartment in healthy participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodegenerative Diseases, Activities of Daily Living, Aging
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-center prospective non-inferiority study
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental_Arm
Arm Type
Experimental
Arm Description
Assessment of behavior during day and night by unobtrusive sensors
Intervention Type
Other
Intervention Name(s)
Monitoring by unobtrusive sensors
Intervention Description
During the study the behavior of daily activities will be monitored by unobstructive sensors. Most of the sensors will be mounted on the wall or on furniture with direct sight to the participant and thus will not have any physical contact, except some wearables during the stay in the apartment and at home (e.g. watch, mobile polysomnography).
Primary Outcome Measure Information:
Title
Heart rate (Vital parameters)
Description
The heart rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Time Frame
1 Week / Continuously
Title
Respiration rate (Vital parameters)
Description
The respiration rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Time Frame
1 Week / Continuously
Title
Oxygen saturation (Vital parameters)
Description
The oxygen saturation will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Time Frame
1 Week / Continuously
Title
Systolic / Diastolic blood pressure (Vital parameters)
Description
The blood pressure will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Time Frame
1 Week / Continuously
Title
Skin conductance (Vital parameters)
Description
The skin conductance will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Time Frame
1 Week / Continuously
Secondary Outcome Measure Information:
Title
3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
Description
The pose will be assessed continuously by pressure sensors, radar sensors, accelerometer, gyroscope, motion tracking (gold standard), lidar sensors, piir sensors.
Time Frame
1 Week / Continuously
Other Pre-specified Outcome Measures:
Title
Usability
Description
The usability of the sensor system will be assessed by the System usability scale (SUS). The score range is between 0 and 100, whereas the higher score means higher usability.
Time Frame
Each day / 7x
Title
Doors open and closed (Activities of daily living)
Description
Unit: 1 open, 0 closed.
Time Frame
1 Week / Continuously
Title
Power used - Power Plugs (Activities of daily living)
Description
Unit: Watt.
Time Frame
1 Week / Continuously
Title
Temperature (Activities of daily living)
Description
Unit: Degree Celsius.
Time Frame
1 Week / Continuously
Title
Relative Humidity (Activities of daily living)
Description
Unit: Percent - Relative to a maximum humidity given the same temperature.
Time Frame
1 Week / Continuously
Title
Brightness (Activities of daily living)
Description
Unit: Lux.
Time Frame
1 Week / Continuously
Title
Accelerometer - Wearable (Activities of daily living)
Description
Unit: m/s^2.
Time Frame
1 Week / Continuously
Title
Electrocardiography (ECG) - Wearable (Activities of daily living)
Description
Unit: Component of the ECG (QRS Complex).
Time Frame
1 Week / Continuously
Title
Cognition 1
Description
Cognition will be assessed by the Montreal Cognitive Assessment (MoCA). Scores of the MoCA range from 0 to 30, with a score of 26 and higher generally considered normal.
Time Frame
Measured on the first day / 1x
Title
Cognition 2
Description
Cognition will be assessed by the Mini-Mental State Examination (MMSE). Scores of the MMSE range from 0 to 30, with a score of 25 and higher generally considered normal.
Time Frame
Measured on the first day / 1x
Title
Health-related quality of life
Description
Health-related quality of life will be assessed by the EuroQol (EQ-5D-5L).The EQ-5D-5L comprises five questions on mobility, self-care, pain, usual activities, and psychological status. The questions have five possible answers for each item (no problems - unable to).
Time Frame
Measured on the first and last day / 2x
Title
Sleep quality
Description
Sleep quality will be assessed by the SF A/R. The inventory estimates the total sleep duration (calculated from items 'bedtime in the evening' and 'wake-up time in morning'), time awake after sleep onset, and sleep onset latency (5-point Likert scale).
Time Frame
Each day / 7x
Title
Chronotype
Description
The Chronotype will be assessed by the D-MEQ. The D-MEQ scores range between 13 and 86. High sum scores (59-86) are associated to morningness, while lower scores point to eveningness (16-41).
Time Frame
Measured on the first day / 1x
Title
Depression 1
Description
Depression will be assessed by the Geriatric Depression Scale (GDS). The inventory has 15 questions (yes/no). Scores of 0-4 are considered normal and 12-15 indicate severe depression.
Time Frame
Measured on the first day / 1x
Title
Depression 2
Description
Depression will be assessed by the Beck Depression Inventory (BDI). The inventory has 21 questions (yes/no). Scores of 1-10 are considered normal and over 40 indicate severe depression.
Time Frame
Measured on the first day / 1x
Title
Physical activity
Description
Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ). The IPAQ assesses the time spent on walking, doing moderate-intensity and vigorous-intensity activity within the domains of work, transportation, domestic and gardening (yard) activities, and leisure-related activities.
Time Frame
Measured on the first day / 1x
Title
Grip strength
Description
Grip strength will be assessed by a dynamometer.
Time Frame
Measured on the first day / 1x
Title
Fall risk
Description
Fall risk will be assessed by the Time Up and Go Test (TUG).
Time Frame
Measured on the first day / 1x
Title
Gait and balance
Description
Gait and balance will be assessed by the Tinetti Balance and Gait Test (POMA).
Time Frame
Measured on the first day / 1x
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Aged ≥18 years
German speaking
Exclusion Criteria:
Infected by multidrug-resistant bacteria according to current medical history
Incontinence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan M Gerber, PhD
Organizational Affiliation
Gerontechnology & Rehabilitation Group, University of Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
City
Bern
State/Province
Ber
ZIP/Postal Code
3008
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available after the publication of the results upon request.
Citations:
PubMed Identifier
15383148
Citation
Andersen CK, Wittrup-Jensen KU, Lolk A, Andersen K, Kragh-Sorensen P. Ability to perform activities of daily living is the main factor affecting quality of life in patients with dementia. Health Qual Life Outcomes. 2004 Sep 21;2:52. doi: 10.1186/1477-7525-2-52.
Results Reference
background
PubMed Identifier
32760739
Citation
Saner H, Schutz N, Botros A, Urwyler P, Buluschek P, du Pasquier G, Nef T. Potential of Ambient Sensor Systems for Early Detection of Health Problems in Older Adults. Front Cardiovasc Med. 2020 Jul 15;7:110. doi: 10.3389/fcvm.2020.00110. eCollection 2020.
Results Reference
background
PubMed Identifier
31273234
Citation
Schutz N, Saner H, Rudin B, Botros A, Pais B, Santschi V, Buluschek P, Gatica-Perez D, Urwyler P, Marchal-Crespo L, Muri RM, Nef T. Validity of pervasive computing based continuous physical activity assessment in community-dwelling old and oldest-old. Sci Rep. 2019 Jul 4;9(1):9662. doi: 10.1038/s41598-019-45733-8.
Results Reference
background
PubMed Identifier
28176828
Citation
Urwyler P, Stucki R, Rampa L, Muri R, Mosimann UP, Nef T. Cognitive impairment categorized in community-dwelling older adults with and without dementia using in-home sensors that recognise activities of daily living. Sci Rep. 2017 Feb 8;7:42084. doi: 10.1038/srep42084.
Results Reference
background
PubMed Identifier
23305821
Citation
Wimo A, Jonsson L, Bond J, Prince M, Winblad B; Alzheimer Disease International. The worldwide economic impact of dementia 2010. Alzheimers Dement. 2013 Jan;9(1):1-11.e3. doi: 10.1016/j.jalz.2012.11.006.
Results Reference
background
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Validation of the NeuroTec Loft
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