NCT06090942

Brief Summary

This study aims to conduct cognitive training for digital biomarkers among older adults.

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

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

August 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

August 16, 2023

Last Update Submit

October 15, 2023

Conditions

Cognitive DeclineHealthy Aging

Keywords

digital biomarker

Outcome Measures

Primary Outcomes (1)

  • digital biomarker

    wearable device of stress and sleep, EEG power in alpha band, Delta and Theta frequency-bands

    pretest, immediate post test, 3 month follow-up, 6 month follow-up

Secondary Outcomes (5)

  • Montreal Cognitive Assessment(MoCA)

    pretest, immediate post test, 3 month follow-up, 6 month follow-up

  • Digit Span(DS)

    pretest, immediate post test, 3 month follow-up, 6 month follow-up

  • Digit Vigilance Test(DVT)

    pretest, immediate post test, 3 month follow-up, 6 month follow-up

  • Computerized version of Wisconsin Card Sort Test (WCST)

    pretest, immediate post test, 3 month follow-up, 6 month follow-up

  • Stroop color-word test (SCWT)

    pretest, immediate post test, 3 month follow-up, 6 month follow-up

Study Arms (2)

Cognitive training

EXPERIMENTAL

Smartphone-based cognitive training

Other: Smartphone-based cognitive training

Usual care

NO INTERVENTION

No intervention

Interventions

Smartphone-based cognitive trainingOTHER

Smartphone-based cognitive training

Cognitive training

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 60 years of age, Can communicate in Chinese (Taiwanese)
  • Bring your own mobile device with Internet access.
  • Can act alone without physical impairment；full score of basic activities of daily living scale and instrumental activities of daily living scale.

You may not qualify if:

  • Dementia diagnosed by a physician and in compliance with ICD-10
  • Physician diagnosed with significant mental illness or communication impairment
  • Participated in other cognitive training studies within the past year
  • Medical conditions associated with rapid functional and cognitive decline
  • Severe visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 16, 2023

First Posted

October 19, 2023

Study Start

October 20, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share