Clinical trial NCT04793555: Validation of the NeuroTec Loft
Official title: Validation of an Apartment to Monitor Human Behaviour During Day and Night
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodegenerative Diseases
Activities of Daily Living
Aging
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2021-03-11
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-center prospective non-inferiority study
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Heart rate (Vital parameters)
timeFrame: 1 Week / Continuously
measure: Respiration rate (Vital parameters)
timeFrame: 1 Week / Continuously
measure: Oxygen saturation (Vital parameters)
timeFrame: 1 Week / Continuously
measure: Systolic / Diastolic blood pressure (Vital parameters)
timeFrame: 1 Week / Continuously
measure: Skin conductance (Vital parameters)
timeFrame: 1 Week / Continuously
Secondary outcomes:
measure: 3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
timeFrame: 1 Week / Continuously
Other outcomes:
measure: Usability
timeFrame: Each day / 7x
measure: Doors open and closed (Activities of daily living)
timeFrame: 1 Week / Continuously
measure: Power used - Power Plugs (Activities of daily living)
timeFrame: 1 Week / Continuously
measure: Temperature (Activities of daily living)
timeFrame: 1 Week / Continuously
measure: Relative Humidity (Activities of daily living)
timeFrame: 1 Week / Continuously
measure: Brightness (Activities of daily living)
timeFrame: 1 Week / Continuously
measure: Accelerometer - Wearable (Activities of daily living)
timeFrame: 1 Week / Continuously
measure: Electrocardiography (ECG) - Wearable (Activities of daily living)
timeFrame: 1 Week / Continuously
measure: Cognition 1
timeFrame: Measured on the first day / 1x
measure: Cognition 2
timeFrame: Measured on the first day / 1x
measure: Health-related quality of life
timeFrame: Measured on the first and last day / 2x
measure: Sleep quality
timeFrame: Each day / 7x
measure: Chronotype
timeFrame: Measured on the first day / 1x
measure: Depression 1
timeFrame: Measured on the first day / 1x
measure: Depression 2
timeFrame: Measured on the first day / 1x
measure: Physical activity
timeFrame: Measured on the first day / 1x
measure: Grip strength
timeFrame: Measured on the first day / 1x
measure: Fall risk
timeFrame: Measured on the first day / 1x
measure: Gait and balance
timeFrame: Measured on the first day / 1x
Locations:
city: Bern
country: Switzerland
facility: ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
state: Ber
Study officials:
affiliation: Gerontechnology & Rehabilitation Group, University of Bern, Switzerland
name: Stephan M Gerber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.