Validation of the NeuroTec Loft
2022년 8월 10일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
104
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ber
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Bern, Ber, 스위스, 3008
- ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Written informed consent
- Aged ≥18 years
- German speaking
Exclusion Criteria:
- Infected by multidrug-resistant bacteria according to current medical history
- Incontinence
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Heart rate (Vital parameters)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Usability
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Stephan M Gerber, PhD, Gerontechnology & Rehabilitation Group, University of Bern, Switzerland
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 6월 1일
기본 완료 (실제)
2022년 2월 28일
연구 완료 (실제)
2022년 7월 29일
연구 등록 날짜
최초 제출
2021년 3월 3일
QC 기준을 충족하는 최초 제출
2021년 3월 8일
처음 게시됨 (실제)
2021년 3월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 8월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 8월 10일
마지막으로 확인됨
2022년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .