Mild Cognitive Impairment, DementiaNCT03120741
Dementia Patient's Behavior Evaluation Using Noninvasive Ambient Sensor
An observational study of Mild Cognitive Impairment, Dementia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study is an observational study that uses daily activity and environmental sensing techniques to establish behavioral models of early dementia patients and cognitive healthy function to assess their daily behavior and determine their activities. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Dementia
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2017to Aug 2018
- Phase
- Observational
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The age of the subject is over 65. The education level is junior high school degree or above. The healthy elders will be selected by the MMSE score (over 24), AD-8 score (under 2) and the Mini-Cog (over 4). The MMSE score of the subjects with cognitive impairment or dementia is 10 to 23.
Who may be able to join
- Can communicate in Mandarin or Taiwanese.
- Consciousness is clear.
- Can do the daily activity by their own.
Who cannot join
- Have a serious cardiopulmonary disease or physical activity is limited to those unable to carry out daily activities.
- Consciousness is not clear.
- Difficult communication, such as: aphasia patients, the use of respirator patients.
- Suffering from serious mental illness that can not match.
- Adopt absolute isolation, such as: open tuberculosis patients.
- Hearing or severe visual impairment that can not match.
- Can not exercise their consent.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 10617
Li-Chen Fu, Doctor, +886-2-3366-4888 ext. 533, lichen@ntu.edu.tw
About this study
This study is an observational study that uses daily activity and environmental sensing techniques to establish behavioral models of early dementia patients and cognitive healthy function to assess their daily behavior and determine their activities. Specifically, the team will collect information on a number of wireless sensors for dementia, mild cognitive impairment and healthy elderly residents, and use special mathematical models to establish the behavior of the two groups of subjects Model. The model will be developed a reliable algorithm to assess health risk of the subjects.
Read the detailed description
With the help of intelligent home environment and Pervasive Computing, it is possible to bring information about the behavior of the patients to the caregivers and their relatives. In this study, non-invasive wireless sensors such as infrared motion sensor the switch sensor will be built in the home of the subjects. The wireless sensor data collected by the input to the team's "activity identification system" in order to assess the mathematical model of the subjects "capacity" and immediate judgment of their activities. In the identification of activities can be divided into two categories of behavior, risk behavior (harmful to the subjects) and protective behavior (beneficial to the subjects), real-time activity detection, can avoid dangerous behavior, such as water and gas off, roaming , Repetitive behavior (over-eating), forgetting to eat and day-night reversal (sleep disturbance), etc., the protection of behavior can be observed through a long time to help patients conduct beneficial behavior, such as regular quantitative diet.
- Conditions
- Mild Cognitive Impairment, Dementia
- Keywords
- Healthcare Quality
- Medical subject headings
- Cognitive Dysfunction, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between moving pattern change and dementia.
Motion sensors will be installed on the ceiling. We will analyze multiple sensors to see how the participant move from one location to another. The data whether the participant is wandering or not and times of wandering will be measured.
Measured: 6 months
The relationship between daily routine change and dementia.
Motion sensors, switch sensors, and current sensors will be installed in the home of the participant.
The room which the participant is in, the appliance which the participant is using will be measured.
Measured: 6 months
The relationship between sleeping time change and dementia.
Motion sensors will be installed in the bed or on the ceiling. The time when the participant goes to sleep, and the times the participant turns over during sleep will be measured.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startMay 2017 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment, DementiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Chen Fu, Doctor, Principal investigator, National Taiwan University, Department of Computer Science & Information Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120741
- Sponsor's protocol ID
- 201608004RINB
- Status last verified
- Dec 2016
- First submitted
- 15 Nov 2016
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia Patient's Behavior Evaluation Using Noninvasive Ambient Sensor
- ClinicalTrials.gov ID
- NCT03120741
- Acronym / sponsor ID
- 201608004RINB
- Conditions
- Mild Cognitive Impairment, Dementia
- Keywords
- Healthcare Quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 19 Apr 2017 (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.
This study is an observational study that uses daily activity and environmental sensing techniques to establish behavioral models of early dementia patients and cognitive healthy function to assess their daily behavior and determine their activities. Specifically, the team will collect information on a number of wireless sensors for dementia, mild cognitive impairment and healthy elderly residents, and use special mathematical models to establish the behavior of the two groups of subjects Model. The model will be developed a reliable algorithm to assess health risk of the subjects.
Detailed description
With the help of intelligent home environment and Pervasive Computing, it is possible to bring information about the behavior of the patients to the caregivers and their relatives. In this study, non-invasive wireless sensors such as infrared motion sensor the switch sensor will be built in the home of the subjects. The wireless sensor data collected by the input to the team's "activity identification system" in order to assess the mathematical model of the subjects "capacity" and immediate judgment of their activities. In the identification of activities can be divided into two categories of behavior, risk behavior (harmful to the subjects) and protective behavior (beneficial to the subjects), real-time activity detection, can avoid dangerous behavior, such as water and gas off, roaming , Repetitive behavior (over-eating), forgetting to eat and day-night reversal (sleep disturbance), etc., the protection of behavior can be observed through a long time to help patients conduct beneficial behavior, such as regular quantitative diet.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The age of the subject is over 65. The education level is junior high school degree or above. The healthy elders will be selected by the MMSE score (over 24), AD-8 score (under 2) and the Mini-Cog (over 4). The MMSE score of the subjects with cognitive impairment or dementia is 10 to 23.
Key inclusion criteria (3 listed)
- Can communicate in Mandarin or Taiwanese.
- Consciousness is clear.
- Can do the daily activity by their own.
Key exclusion criteria (7 listed)
- Have a serious cardiopulmonary disease or physical activity is limited to those unable to carry out daily activities.
- Consciousness is not clear.
- Difficult communication, such as: aphasia patients, the use of respirator patients.
- Suffering from serious mental illness that can not match.
- Adopt absolute isolation, such as: open tuberculosis patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relationship between moving pattern change and dementia.
Time frame: 6 months
Motion sensors will be installed on the ceiling. We will analyze multiple sensors to see how the participant move from one location to another. The data whether the participant is wandering or not and times of wandering will be measured.
The relationship between daily routine change and dementia.
Time frame: 6 months
Motion sensors, switch sensors, and current sensors will be installed in the home of the participant. The room which the participant is in, the appliance which the participant is using will be measured.
The relationship between sleeping time change and dementia.
Time frame: 6 months
Motion sensors will be installed in the bed or on the ceiling. The time when the participant goes to sleep, and the times the participant turns over during sleep will be measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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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.
Li-Chen Fu, Doctor principal investigator
National Taiwan University, Department of Computer Science & Information Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, Dementia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 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: status not confirmed, as of the sponsor's last update on 19 Apr 2017. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Chen Fu, Doctor (+886-2-3366-4888 ext. 533, lichen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between moving pattern change and dementia. (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2017.