Validation of the NeuroTec Loft

NCT04793555 | Completed

• 1 other identifier: NLoft_H_1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurodegenerative Diseases; Activities of Daily Living; Aging

Outcome Measures

Primary Outcomes (5)

• Heart rate (Vital parameters)

  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)

  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)

  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)

  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)

  The skin conductance will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).

  1 Week / Continuously

Secondary Outcomes (1)

• 3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)

  1 Week / Continuously

Other Outcomes (19)

• Usability

  Each day / 7x

• Doors open and closed (Activities of daily living)

  1 Week / Continuously

• Power used - Power Plugs (Activities of daily living)

  1 Week / Continuously

Study Arms (1)

Experimental_Arm

EXPERIMENTAL

Assessment of behavior during day and night by unobtrusive sensors

Other: Monitoring by unobtrusive sensors

Interventions

Monitoring by unobtrusive sensors OTHER

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).

Experimental_Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Aged ≥18 years
• German speaking

You may not qualify if:

• Infected by multidrug-resistant bacteria according to current medical history
• Incontinence

Sponsors & Collaborators

• University of Bern: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation

Bern, Ber, 3008, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 15383148 BACKGROUND

• 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.

  PMID: 32760739 BACKGROUND

• 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.

  PMID: 31273234 BACKGROUND

• 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.

  PMID: 28176828 BACKGROUND

• 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.

  PMID: 23305821 BACKGROUND

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Stephan M Gerber, PhD

  Gerontechnology & Rehabilitation Group, University of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center prospective non-inferiority study

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 11, 2021
• Study Start: June 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: July 29, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)