Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Validation of the NeuroTec Loft

10. august 2022 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

104

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental_Arm
Assessment of behavior during day and night 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart rate (Vital parameters)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Usability
Tidsramme: 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)
Tidsramme: 1 Week / Continuously
Unit: 1 open, 0 closed.
1 Week / Continuously
Power used - Power Plugs (Activities of daily living)
Tidsramme: 1 Week / Continuously
Unit: Watt.
1 Week / Continuously
Temperature (Activities of daily living)
Tidsramme: 1 Week / Continuously
Unit: Degree Celsius.
1 Week / Continuously
Relative Humidity (Activities of daily living)
Tidsramme: 1 Week / Continuously
Unit: Percent - Relative to a maximum humidity given the same temperature.
1 Week / Continuously
Brightness (Activities of daily living)
Tidsramme: 1 Week / Continuously
Unit: Lux.
1 Week / Continuously
Accelerometer - Wearable (Activities of daily living)
Tidsramme: 1 Week / Continuously
Unit: m/s^2.
1 Week / Continuously
Electrocardiography (ECG) - Wearable (Activities of daily living)
Tidsramme: 1 Week / Continuously
Unit: Component of the ECG (QRS Complex).
1 Week / Continuously
Cognition 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Measured on the first day / 1x
Grip strength will be assessed by a dynamometer.
Measured on the first day / 1x
Fall risk
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Stephan M Gerber, PhD, Gerontechnology & Rehabilitation Group, University of Bern, Switzerland

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2021

Primær færdiggørelse (Faktiske)

28. februar 2022

Studieafslutning (Faktiske)

29. juli 2022

Datoer for studieregistrering

Først indsendt

3. marts 2021

Først indsendt, der opfyldte QC-kriterier

8. marts 2021

Først opslået (Faktiske)

11. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NLoft_H_1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Data will be available after the publication of the results upon request.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner