Validation of the NeuroTec Loft
10. August 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
104
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Ber
-
Bern, Ber, Schweiz, 3008
- ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Written informed consent
- Aged ≥18 years
- German speaking
Exclusion Criteria:
- Infected by multidrug-resistant bacteria according to current medical history
- Incontinence
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Heart rate (Vital parameters)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Usability
Zeitfenster: 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)
Zeitfenster: 1 Week / Continuously
|
Unit: 1 open, 0 closed.
|
1 Week / Continuously
|
|
Power used - Power Plugs (Activities of daily living)
Zeitfenster: 1 Week / Continuously
|
Unit: Watt.
|
1 Week / Continuously
|
|
Temperature (Activities of daily living)
Zeitfenster: 1 Week / Continuously
|
Unit: Degree Celsius.
|
1 Week / Continuously
|
|
Relative Humidity (Activities of daily living)
Zeitfenster: 1 Week / Continuously
|
Unit: Percent - Relative to a maximum humidity given the same temperature.
|
1 Week / Continuously
|
|
Brightness (Activities of daily living)
Zeitfenster: 1 Week / Continuously
|
Unit: Lux.
|
1 Week / Continuously
|
|
Accelerometer - Wearable (Activities of daily living)
Zeitfenster: 1 Week / Continuously
|
Unit: m/s^2.
|
1 Week / Continuously
|
|
Electrocardiography (ECG) - Wearable (Activities of daily living)
Zeitfenster: 1 Week / Continuously
|
Unit: Component of the ECG (QRS Complex).
|
1 Week / Continuously
|
|
Cognition 1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Measured on the first day / 1x
|
Grip strength will be assessed by a dynamometer.
|
Measured on the first day / 1x
|
|
Fall risk
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Stephan M Gerber, PhD, Gerontechnology & Rehabilitation Group, University of Bern, Switzerland
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juni 2021
Primärer Abschluss (Tatsächlich)
28. Februar 2022
Studienabschluss (Tatsächlich)
29. Juli 2022
Studienanmeldedaten
Zuerst eingereicht
3. März 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. März 2021
Zuerst gepostet (Tatsächlich)
11. März 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. August 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. August 2022
Zuletzt verifiziert
1. August 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NLoft_H_1
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Data will be available after the publication of the results upon request.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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