Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03120741
Other study ID # 201608004RINB
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 15, 2016
Last updated April 14, 2017
Start date May 2017
Est. completion date August 2018

Study information

Verified date December 2016
Source National Taiwan University Hospital
Contact Li-Chen Fu, Doctor
Phone +886-2-3366-4888
Email lichen@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 35
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 100 Years
Eligibility Inclusion criteria:

- Can communicate in Mandarin or Taiwanese.

- Consciousness is clear.

- Can do the daily activity by their own.

Exclusion criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary 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.
6 months
Primary 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. 6 months