Validation of the NeuroTec Loft
10 août 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
104
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Ber
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Bern, Ber, Suisse, 3008
- ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Written informed consent
- Aged ≥18 years
- German speaking
Exclusion Criteria:
- Infected by multidrug-resistant bacteria according to current medical history
- Incontinence
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Heart rate (Vital parameters)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Usability
Délai: 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)
Délai: 1 Week / Continuously
|
Unit: 1 open, 0 closed.
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1 Week / Continuously
|
|
Power used - Power Plugs (Activities of daily living)
Délai: 1 Week / Continuously
|
Unit: Watt.
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1 Week / Continuously
|
|
Temperature (Activities of daily living)
Délai: 1 Week / Continuously
|
Unit: Degree Celsius.
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1 Week / Continuously
|
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Relative Humidity (Activities of daily living)
Délai: 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)
Délai: 1 Week / Continuously
|
Unit: Lux.
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1 Week / Continuously
|
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Accelerometer - Wearable (Activities of daily living)
Délai: 1 Week / Continuously
|
Unit: m/s^2.
|
1 Week / Continuously
|
|
Electrocardiography (ECG) - Wearable (Activities of daily living)
Délai: 1 Week / Continuously
|
Unit: Component of the ECG (QRS Complex).
|
1 Week / Continuously
|
|
Cognition 1
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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Grip strength
Délai: Measured on the first day / 1x
|
Grip strength will be assessed by a dynamometer.
|
Measured on the first day / 1x
|
|
Fall risk
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Stephan M Gerber, PhD, Gerontechnology & Rehabilitation Group, University of Bern, Switzerland
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2021
Achèvement primaire (Réel)
28 février 2022
Achèvement de l'étude (Réel)
29 juillet 2022
Dates d'inscription aux études
Première soumission
3 mars 2021
Première soumission répondant aux critères de contrôle qualité
8 mars 2021
Première publication (Réel)
11 mars 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 août 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 août 2022
Dernière vérification
1 août 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NLoft_H_1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Data will be available after the publication of the results upon request.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .