Validation of the NeuroTec Loft

August 10, 2022 updated by: University of Bern

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 Week / Continuously
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).
1 Week / Continuously
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).
1 Week / Continuously
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).
1 Week / Continuously
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).
1 Week / Continuously

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 Week / Continuously

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Each day / 7x
Doors open and closed (Activities of daily living)
Time Frame: 1 Week / Continuously
Unit: 1 open, 0 closed.
1 Week / Continuously
Power used - Power Plugs (Activities of daily living)
Time Frame: 1 Week / Continuously
Unit: Watt.
1 Week / Continuously
Temperature (Activities of daily living)
Time Frame: 1 Week / Continuously
Unit: Degree Celsius.
1 Week / Continuously
Relative Humidity (Activities of daily living)
Time Frame: 1 Week / Continuously
Unit: Percent - Relative to a maximum humidity given the same temperature.
1 Week / Continuously
Brightness (Activities of daily living)
Time Frame: 1 Week / Continuously
Unit: Lux.
1 Week / Continuously
Accelerometer - Wearable (Activities of daily living)
Time Frame: 1 Week / Continuously
Unit: m/s^2.
1 Week / Continuously
Electrocardiography (ECG) - Wearable (Activities of daily living)
Time Frame: 1 Week / Continuously
Unit: Component of the ECG (QRS Complex).
1 Week / Continuously
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.
Measured on the first day / 1x
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.
Measured on the first day / 1x
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).
Measured on the first and last day / 2x
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).
Each day / 7x
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).
Measured on the first day / 1x
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.
Measured on the first day / 1x
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.
Measured on the first day / 1x
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.
Measured on the first day / 1x
Grip strength
Time Frame: Measured on the first day / 1x
Grip strength will be assessed by a dynamometer.
Measured on the first day / 1x
Fall risk
Time Frame: Measured on the first day / 1x
Fall risk will be assessed by the Time Up and Go Test (TUG).
Measured on the first day / 1x
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).
Measured on the first day / 1x

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital Inselspital, Berne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephan M Gerber, PhD, Gerontechnology & Rehabilitation Group, University of Bern, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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