Validation of the NeuroTec Loft
10 sierpnia 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
104
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Ber
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Bern, Ber, Szwajcaria, 3008
- ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Written informed consent
- Aged ≥18 years
- German speaking
Exclusion Criteria:
- Infected by multidrug-resistant bacteria according to current medical history
- Incontinence
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Heart rate (Vital parameters)
Ramy czasowe: 1 Week / Continuously
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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)
Ramy czasowe: 1 Week / Continuously
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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)
Ramy czasowe: 1 Week / Continuously
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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)
Ramy czasowe: 1 Week / Continuously
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The blood pressure 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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Skin conductance (Vital parameters)
Ramy czasowe: 1 Week / Continuously
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The skin conductance 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
Ramy czasowe: 1 Week / Continuously
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The pose will be assessed continuously by pressure sensors, radar sensors, accelerometer, gyroscope, motion tracking (gold standard), lidar sensors, piir sensors.
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1 Week / Continuously
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Usability
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 1 Week / Continuously
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Unit: Watt.
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1 Week / Continuously
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Temperature (Activities of daily living)
Ramy czasowe: 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)
Ramy czasowe: 1 Week / Continuously
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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)
Ramy czasowe: 1 Week / Continuously
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Unit: Lux.
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1 Week / Continuously
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Accelerometer - Wearable (Activities of daily living)
Ramy czasowe: 1 Week / Continuously
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Unit: m/s^2.
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1 Week / Continuously
|
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Electrocardiography (ECG) - Wearable (Activities of daily living)
Ramy czasowe: 1 Week / Continuously
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Unit: Component of the ECG (QRS Complex).
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1 Week / Continuously
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Cognition 1
Ramy czasowe: Measured on the first day / 1x
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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.
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Measured on the first day / 1x
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Cognition 2
Ramy czasowe: Measured on the first day / 1x
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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.
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Measured on the first day / 1x
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Health-related quality of life
Ramy czasowe: Measured on the first and last day / 2x
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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
Ramy czasowe: Each day / 7x
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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
Ramy czasowe: Measured on the first day / 1x
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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
Ramy czasowe: Measured on the first day / 1x
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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
Ramy czasowe: Measured on the first day / 1x
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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.
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Measured on the first day / 1x
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Physical activity
Ramy czasowe: 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
Ramy czasowe: Measured on the first day / 1x
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Grip strength will be assessed by a dynamometer.
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Measured on the first day / 1x
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Fall risk
Ramy czasowe: Measured on the first day / 1x
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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
Ramy czasowe: Measured on the first day / 1x
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Gait and balance will be assessed by the Tinetti Balance and Gait Test (POMA).
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Measured on the first day / 1x
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Stephan M Gerber, PhD, Gerontechnology & Rehabilitation Group, University of Bern, Switzerland
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 czerwca 2021
Zakończenie podstawowe (Rzeczywisty)
28 lutego 2022
Ukończenie studiów (Rzeczywisty)
29 lipca 2022
Daty rejestracji na studia
Pierwszy przesłany
3 marca 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
8 marca 2021
Pierwszy wysłany (Rzeczywisty)
11 marca 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
11 sierpnia 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
10 sierpnia 2022
Ostatnia weryfikacja
1 sierpnia 2022
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NLoft_H_1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
Data will be available after the publication of the results upon request.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .