Validation of the NeuroTec Loft

Validation of an Apartment to Monitor Human Behaviour During Day and Night

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.

Study Overview

• Status: Completed
• Conditions: Neurodegenerative Diseases; Aging; Activities of Daily Living
• Intervention / Treatment: Other: Monitoring by unobtrusive sensors

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Ber
    • Bern, Ber, Switzerland, 3008
      • ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• Aged ≥18 years
• German speaking

Exclusion Criteria:

• Infected by multidrug-resistant bacteria according to current medical history
• Incontinence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental_Arm; Assessment of behavior during day and night by unobtrusive sensors	Other: Monitoring by unobtrusive sensors; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate (Vital parameters)	The heart rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).	1 Week / Continuously
Respiration rate (Vital parameters)	The respiration rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).	1 Week / Continuously
Oxygen saturation (Vital parameters)	The oxygen saturation will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).	1 Week / Continuously
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).	1 Week / Continuously
Skin conductance (Vital parameters)	The skin conductance will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).	1 Week / Continuously

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Week / Continuously

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	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.	Each day / 7x
Doors open and closed (Activities of daily living)	Unit: 1 open, 0 closed.	1 Week / Continuously
Power used - Power Plugs (Activities of daily living)	Unit: Watt.	1 Week / Continuously
Temperature (Activities of daily living)	Unit: Degree Celsius.	1 Week / Continuously
Relative Humidity (Activities of daily living)	Unit: Percent - Relative to a maximum humidity given the same temperature.	1 Week / Continuously
Brightness (Activities of daily living)	Unit: Lux.	1 Week / Continuously
Accelerometer - Wearable (Activities of daily living)	Unit: m/s^2.	1 Week / Continuously
Electrocardiography (ECG) - Wearable (Activities of daily living)	Unit: Component of the ECG (QRS Complex).	1 Week / Continuously
Cognition 1	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.	Measured on the first day / 1x
Cognition 2	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.	Measured on the first day / 1x
Health-related quality of life	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).	Measured on the first and last day / 2x
Sleep quality	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).	Each day / 7x
Chronotype	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).	Measured on the first day / 1x
Depression 1	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.	Measured on the first day / 1x
Depression 2	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.	Measured on the first day / 1x
Physical activity	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.	Measured on the first day / 1x
Grip strength	Grip strength will be assessed by a dynamometer.	Measured on the first day / 1x
Fall risk	Fall risk will be assessed by the Time Up and Go Test (TUG).	Measured on the first day / 1x
Gait and balance	Gait and balance will be assessed by the Tinetti Balance and Gait Test (POMA).	Measured on the first day / 1x

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Stephan M Gerber, PhD, Gerontechnology & Rehabilitation Group, University of Bern, Switzerland

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): July 29, 2022

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurodegenerative Diseases
• Other Study ID Numbers: NLoft_H_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available after the publication of the results upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No