Validation of the NeuroTec Loft
2022年8月10日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
104
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Ber
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Bern、Ber、スイス、3008
- ARTORG Center for Biomedical Engineering, Gerontechnology and Rehabilitation
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Written informed consent
- Aged ≥18 years
- German speaking
Exclusion Criteria:
- Infected by multidrug-resistant bacteria according to current medical history
- Incontinence
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Heart rate (Vital parameters)
時間枠：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)
時間枠：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
|
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Oxygen saturation (Vital parameters)
時間枠：1 Week / Continuously
|
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
|
|
Systolic / Diastolic blood pressure (Vital parameters)
時間枠：1 Week / Continuously
|
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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
3D Model (Coordinates of the joints over time) of the participant in the apartment (Movement parameters)
時間枠：1 Week / Continuously
|
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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Usability
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：1 Week / Continuously
|
Unit: Component of the ECG (QRS Complex).
|
1 Week / Continuously
|
|
Cognition 1
時間枠：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
|
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Cognition 2
時間枠：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
|
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Health-related quality of life
時間枠：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
時間枠：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
時間枠：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).
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Measured on the first day / 1x
|
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Depression 1
時間枠：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.
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Measured on the first day / 1x
|
|
Depression 2
時間枠：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.
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Measured on the first day / 1x
|
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Physical activity
時間枠：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
時間枠：Measured on the first day / 1x
|
Grip strength will be assessed by a dynamometer.
|
Measured on the first day / 1x
|
|
Fall risk
時間枠：Measured on the first day / 1x
|
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
時間枠：Measured on the first day / 1x
|
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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Stephan M Gerber, PhD、Gerontechnology & Rehabilitation Group, University of Bern, Switzerland
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年6月1日
一次修了 (実際)
2022年2月28日
研究の完了 (実際)
2022年7月29日
試験登録日
最初に提出
2021年3月3日
QC基準を満たした最初の提出物
2021年3月8日
最初の投稿 (実際)
2021年3月11日
学習記録の更新
投稿された最後の更新 (実際)
2022年8月11日
QC基準を満たした最後の更新が送信されました
2022年8月10日
最終確認日
2022年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。