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Completed

NCT Number: NCT04793555

Validation of the NeuroTec Loft

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.

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Key information

Conditions

Neurodegenerative Diseases Activities of Daily Living Aging Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation

Bern, Ber, 3008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Monitoring by unobtrusive sensors

Other

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 outcomes

  1. Heart rate (Vital parameters)

    Time frame: 1 Week / Continuously

    The heart rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).

  2. Respiration rate (Vital parameters)

    Time frame: 1 Week / Continuously

    The respiration rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).

  3. Oxygen saturation (Vital parameters)

    Time frame: 1 Week / Continuously

    The oxygen saturation will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).

  4. Systolic / Diastolic blood pressure (Vital parameters)

    Time frame: 1 Week / Continuously

    The blood pressure will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).

  5. Skin conductance (Vital parameters)

    Time frame: 1 Week / Continuously

    The skin conductance will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).

Secondary outcomes

  1. 3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)

    Time frame: 1 Week / Continuously

    The pose will be assessed continuously by pressure sensors, radar sensors, accelerometer, gyroscope, motion tracking (gold standard), lidar sensors, piir sensors.

Other outcomes

  1. Usability

    Time frame: Each day / 7x

    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.

  2. Doors open and closed (Activities of daily living)

    Time frame: 1 Week / Continuously

    Unit: 1 open, 0 closed.

  3. Power used - Power Plugs (Activities of daily living)

    Time frame: 1 Week / Continuously

    Unit: Watt.

  4. Temperature (Activities of daily living)

    Time frame: 1 Week / Continuously

    Unit: Degree Celsius.

  5. Relative Humidity (Activities of daily living)

    Time frame: 1 Week / Continuously

    Unit: Percent - Relative to a maximum humidity given the same temperature.

  6. Brightness (Activities of daily living)

    Time frame: 1 Week / Continuously

    Unit: Lux.

  7. Accelerometer - Wearable (Activities of daily living)

    Time frame: 1 Week / Continuously

    Unit: m/s^2.

  8. Electrocardiography (ECG) - Wearable (Activities of daily living)

    Time frame: 1 Week / Continuously

    Unit: Component of the ECG (QRS Complex).

  9. Cognition 1

    Time frame: Measured on the first day / 1x

    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.

  10. Cognition 2

    Time frame: Measured on the first day / 1x

    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.

  11. Health-related quality of life

    Time frame: Measured on the first and last day / 2x

    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).

  12. Sleep quality

    Time frame: Each day / 7x

    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).

  13. Chronotype

    Time frame: Measured on the first day / 1x

    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).

  14. Depression 1

    Time frame: Measured on the first day / 1x

    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.

  15. Depression 2

    Time frame: Measured on the first day / 1x

    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.

  16. Physical activity

    Time frame: Measured on the first day / 1x

    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.

  17. Grip strength

    Time frame: Measured on the first day / 1x

    Grip strength will be assessed by a dynamometer.

  18. Fall risk

    Time frame: Measured on the first day / 1x

    Fall risk will be assessed by the Time Up and Go Test (TUG).

  19. Gait and balance

    Time frame: Measured on the first day / 1x

    Gait and balance will be assessed by the Tinetti Balance and Gait Test (POMA).

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2021
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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