NCT05852912

Brief Summary

Mild mental illnesses such as depression, anxiety, and sleep disorders in the elderly are also major health issues for Taiwanese. Mild mental illnesses that cannot be effectively treated may worsen existing chronic diseases. However, there is a lack of objective, convenient and effective assessment tools for the cognitive, emotional, sleep and other mental health of the elderly. The development of these assessment tools can be used to quantify the degree of abnormality, provide early diagnosis, and evaluate the effectiveness of long-term care. In recent years, the progress of physiological sensing technology and wearable devices,telemedicine devices and various computer information integration software has provided objective clinical data. This study will use "wearable devices", "telemedicine" and "computer information software" to evaluate whether elderly with mild mental illness have a poor prognosis. In this way, an intelligent care model for "cognitive, emotional, sleep and other mental health" for elderly is developed.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 10, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

May 2, 2023

Last Update Submit

May 2, 2023

Conditions

Keywords

Elderlywearable devices

Outcome Measures

Primary Outcomes (1)

  • Actigraphy

    Change in sleep latency (mins) based on actigraphy during the study.

    Four times a year until the study is completed (up to 3 years)

Secondary Outcomes (17)

  • Actigraphy-SOL

    Four times a year until the study is completed (up to 3 years)

  • Actigraphy-TST

    Four times a year until the study is completed (up to 3 years)

  • Actigraphy-SE

    Four times a year until the study is completed (up to 3 years)

  • Actigraphy-WASO

    Four times a year until the study is completed (up to 3 years)

  • Actigraphy-Awake time

    Four times a year until the study is completed (up to 3 years)

  • +12 more secondary outcomes

Other Outcomes (1)

  • Heart rate variability (HRV) device

    Four times a year until the study is completed (up to 3 years)

Study Arms (2)

elders combined with mild mental illness

elders combined with mild mental illness(120 subjects)

elders combined without mild mental illness

elders combined without mild mental illness(120 subjects)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The elderly who's age is more than or equal to 65 years old.

You may qualify if:

  • Age is more than or equal to 65 years old
  • Able to provide informed consent to participate in the research.
  • Can understand the instructions, and coduct the questionnaire assessment and physical function measurement.

You may not qualify if:

  • Those unable to give consent to participate in the research.
  • Those who cannot understand the instructions, difficult to coduct questionnaire assessment and physical function measurement.
  • Severe disease state (respiratory distress requiring intubation or patient with terminal illness) or severe brain injury or severe Dementia.
  • Snstable patients and patients with substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (26)

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  • Lin C, Chin WC, Huang YS, Chu KC, Paiva T, Chen CC, Guilleminault C. Different circadian rest-active rhythms in Kleine-Levin syndrome: a prospective and case-control study. Sleep. 2021 Sep 13;44(9):zsab096. doi: 10.1093/sleep/zsab096.

  • Musiek ES, Bhimasani M, Zangrilli MA, Morris JC, Holtzman DM, Ju YS. Circadian Rest-Activity Pattern Changes in Aging and Preclinical Alzheimer Disease. JAMA Neurol. 2018 May 1;75(5):582-590. doi: 10.1001/jamaneurol.2017.4719.

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MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Yu-Shu Huang

    Principal Investigator

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 10, 2023

Study Start

June 1, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

May 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share