Validation of the NeuroTec Loft

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04793555
• Other study ID #: NLoft_H_1
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 29, 2022

Study information

• Verified date: August 2022
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 29, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Activities of Daily Living
• Aging
• Neurodegenerative Diseases

Intervention

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).

Locations

Country	Name	City	State
Switzerland	ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation	Bern	Ber

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Andersen CK, Wittrup-Jensen KU, Lolk A, Andersen K, Kragh-Sørensen 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. — View Citation

Saner H, Schütz 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. — View Citation

Schütz N, Saner H, Rudin B, Botros A, Pais B, Santschi V, Buluschek P, Gatica-Perez D, Urwyler P, Marchal-Crespo L, Müri 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. — View Citation

Urwyler P, Stucki R, Rampa L, Müri 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. — View Citation

Wimo A, Jönsson 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Doors open and closed (Activities of daily living)	Unit: 1 open, 0 closed.	1 Week / Continuously
Other	Power used - Power Plugs (Activities of daily living)	Unit: Watt.	1 Week / Continuously
Other	Temperature (Activities of daily living)	Unit: Degree Celsius.	1 Week / Continuously
Other	Relative Humidity (Activities of daily living)	Unit: Percent - Relative to a maximum humidity given the same temperature.	1 Week / Continuously
Other	Brightness (Activities of daily living)	Unit: Lux.	1 Week / Continuously
Other	Accelerometer - Wearable (Activities of daily living)	Unit: m/s^2.	1 Week / Continuously
Other	Electrocardiography (ECG) - Wearable (Activities of daily living)	Unit: Component of the ECG (QRS Complex).	1 Week / Continuously
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Grip strength	Grip strength will be assessed by a dynamometer.	Measured on the first day / 1x
Other	Fall risk	Fall risk will be assessed by the Time Up and Go Test (TUG).	Measured on the first day / 1x
Other	Gait and balance	Gait and balance will be assessed by the Tinetti Balance and Gait Test (POMA).	Measured on the first day / 1x
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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