Validation of the NeuroTec Loft

Sponsor
University of Bern (Other)
Overall Status
Completed
CT.gov ID
NCT04793555
Collaborator
University Hospital Inselspital, Berne (Other)
104
1
1
13.9
7.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Monitoring by unobtrusive sensors
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single-center prospective non-inferiority studySingle-center prospective non-inferiority study
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Validation of an Apartment to Monitor Human Behaviour During Day and Night
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
Feb 28, 2022
Actual Study Completion Date :
Jul 29, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Heart rate (Vital parameters) [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) [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) [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) [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) [1 Week / Continuously]

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

Secondary Outcome Measures

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

  1. Usability [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) [1 Week / Continuously]

    Unit: 1 open, 0 closed.

  3. Power used - Power Plugs (Activities of daily living) [1 Week / Continuously]

    Unit: Watt.

  4. Temperature (Activities of daily living) [1 Week / Continuously]

    Unit: Degree Celsius.

  5. Relative Humidity (Activities of daily living) [1 Week / Continuously]

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

  6. Brightness (Activities of daily living) [1 Week / Continuously]

    Unit: Lux.

  7. Accelerometer - Wearable (Activities of daily living) [1 Week / Continuously]

    Unit: m/s^2.

  8. Electrocardiography (ECG) - Wearable (Activities of daily living) [1 Week / Continuously]

    Unit: Component of the ECG (QRS Complex).

  9. Cognition 1 [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 [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 [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 [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 [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 [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 [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 [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 [Measured on the first day / 1x]

    Grip strength will be assessed by a dynamometer.

  18. Fall risk [Measured on the first day / 1x]

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

  19. Gait and balance [Measured on the first day / 1x]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Written informed consent

  • Aged ≥18 years

  • German speaking

Exclusion Criteria:
  • Infected by multidrug-resistant bacteria according to current medical history

  • Incontinence

Contacts and Locations

Locations

Site City State Country Postal Code
1 ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation Bern Ber Switzerland 3008

Sponsors and Collaborators

  • University of Bern
  • University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Stephan M Gerber, PhD, Gerontechnology & Rehabilitation Group, University of Bern, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Bern
ClinicalTrials.gov Identifier:
NCT04793555
Other Study ID Numbers:
  • NLoft_H_1
First Posted:
Mar 11, 2021
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022