Validation of the NeuroTec Loft
10. august 2022 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
104
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Ber
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Bern, Ber, Sveits, 3008
- ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Experimental_Arm
Assessment of behavior during day and night by unobtrusive sensors
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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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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).
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1 Week / Continuously
|
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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).
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1 Week / Continuously
|
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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).
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1 Week / Continuously
|
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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
|
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Usability
Tidsramme: Each day / 7x
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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.
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Each day / 7x
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Doors open and closed (Activities of daily living)
Tidsramme: 1 Week / Continuously
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Unit: 1 open, 0 closed.
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1 Week / Continuously
|
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Power used - Power Plugs (Activities of daily living)
Tidsramme: 1 Week / Continuously
|
Unit: Watt.
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1 Week / Continuously
|
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Temperature (Activities of daily living)
Tidsramme: 1 Week / Continuously
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Unit: Degree Celsius.
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1 Week / Continuously
|
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Relative Humidity (Activities of daily living)
Tidsramme: 1 Week / Continuously
|
Unit: Percent - Relative to a maximum humidity given the same temperature.
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1 Week / Continuously
|
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Brightness (Activities of daily living)
Tidsramme: 1 Week / Continuously
|
Unit: Lux.
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1 Week / Continuously
|
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Accelerometer - Wearable (Activities of daily living)
Tidsramme: 1 Week / Continuously
|
Unit: m/s^2.
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1 Week / Continuously
|
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Electrocardiography (ECG) - Wearable (Activities of daily living)
Tidsramme: 1 Week / Continuously
|
Unit: Component of the ECG (QRS Complex).
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1 Week / Continuously
|
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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
|
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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
|
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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).
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Measured on the first and last day / 2x
|
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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).
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Each day / 7x
|
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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).
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Measured on the first day / 1x
|
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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.
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Measured on the first day / 1x
|
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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
|
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Physical activity
Tidsramme: Measured on the first day / 1x
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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.
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Measured on the first day / 1x
|
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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).
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Measured on the first day / 1x
|
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Stephan M Gerber, PhD, Gerontechnology & Rehabilitation Group, University of Bern, Switzerland
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2021
Primær fullføring (Faktiske)
28. februar 2022
Studiet fullført (Faktiske)
29. juli 2022
Datoer for studieregistrering
Først innsendt
3. mars 2021
Først innsendt som oppfylte QC-kriteriene
8. mars 2021
Først lagt ut (Faktiske)
11. mars 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. august 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. august 2022
Sist bekreftet
1. august 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NLoft_H_1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Data will be available after the publication of the results upon request.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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