Neurodegenerative DiseasesNCT04793555
Validation of the NeuroTec Loft
A study testing Monitoring by unobtrusive sensors in people with Neurodegenerative Diseases and Activities of Daily Living, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases, Activities of Daily Living, Aging
- What is being tested?
- Monitoring by unobtrusive sensors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2021to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Aged ≥18 years
- German speaking
Who cannot join
- Infected by multidrug-resistant bacteria according to current medical history
- Incontinence
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
Bern, Ber, 3008
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Monitoring by unobtrusive sensors
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring by unobtrusive sensorsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental_Arm | Experimental | Assessment of behavior during day and night by unobtrusive sensors Receives: Other: Monitoring by unobtrusive sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate (Vital parameters)
The heart rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 Week / Continuously
Secondary outcomes (1)
3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
The pose will be assessed continuously by pressure sensors, radar sensors, accelerometer, gyroscope, motion tracking (gold standard), lidar sensors, piir sensors.
Measured: 1 Week / Continuously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jun 2021
- Primary completion28 Feb 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center prospective non-inferiority study
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Stephan M Gerber, PhD, Principal investigator, Gerontechnology & Rehabilitation Group, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793555
- Sponsor's protocol ID
- NLoft_H_1
- Status last verified
- Aug 2022
- First submitted
- 3 Mar 2021
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available after the publication of the results upon request.
Publications
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.
PubMed 15383148Saner 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.
PubMed 32760739Schutz 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.
PubMed 31273234Urwyler 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.
PubMed 28176828Wimo 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.
PubMed 23305821
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Apartment to Monitor Human Behaviour During Day and Night
- ClinicalTrials.gov ID
- NCT04793555
- Acronym / sponsor ID
- NLoft_H_1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center prospective non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Experimental_Arm | Experimental | Other: Monitoring by unobtrusive sensorsAssessment of behavior during day and night by unobtrusive sensors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Aged ≥18 years
- German speaking
Key exclusion criteria (2 listed)
- Infected by multidrug-resistant bacteria according to current medical history
- Incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring by unobtrusive sensorsDuring 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). | Other | Experimental_Arm |
Primary outcome
Heart rate (Vital parameters)
Time frame: 1 Week / Continuously
The heart rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Respiration rate (Vital parameters)
Time frame: 1 Week / Continuously
The respiration rate will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Oxygen saturation (Vital parameters)
Time frame: 1 Week / Continuously
The oxygen saturation will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Systolic / Diastolic blood pressure (Vital parameters)
Time frame: 1 Week / Continuously
The blood pressure will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
Skin conductance (Vital parameters)
Time frame: 1 Week / Continuously
The skin conductance will be continuously measured by pressure sensors, radar sensors, infrared camera, galvanic sensor and polysomnography (gold standard).
1 secondary outcome
3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
Time frame: 1 Week / Continuously
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Background: PubMed 15383148Andersen 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.
- Background: PubMed 32760739Saner 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.
- Background: PubMed 31273234Schutz 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.
- Background: PubMed 28176828Urwyler 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.
- Background: PubMed 23305821Wimo 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.
- Individual participant dataSharing planned: No. Data will be available after the publication of the results upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan M Gerber, PhD principal investigator
Gerontechnology & Rehabilitation Group, University of Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring by unobtrusive sensors in people with Neurodegenerative Diseases and Activities of Daily Living, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (Vital parameters) (time frame: 1 Week / Continuously). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04793555, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022; AzTrials last refreshed its copy on 31 Oct 2026.