- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04793555
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
Status
Afsluttet
Intervention / Behandling
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
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Bern, Ber, Schweiz, 3008
- ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
-
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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
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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).
|
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
|
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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).
|
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).
|
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.
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Each day / 7x
|
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Doors open and closed (Activities of daily living)
Tidsramme: 1 Week / Continuously
|
Unit: 1 open, 0 closed.
|
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
|
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
|
|
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.
|
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).
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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).
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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).
|
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.
|
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.
Sponsor
Samarbejdspartnere
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.
Generelle publikationer
- 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.
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)?
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IPD-planbeskrivelse
Data will be available after the publication of the results upon request.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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