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Completed

NCT Number: NCT05380284

Senior Driving Simulation Training for Subjective Cognitive Decline and Mild Cognitive Impairment

This study aims to establish the Senior Driving Simulation Training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI), and explore the effectiveness of Senior Driving Simulation Training (SDST) on the executive function, cognitive function and EEG.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 110, Taiwan

About this study

Driving behavior is a high cognitively demanding task, and whether the Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI) can continue to drive is an important issue. This study will develop the Taiwan version of innovative, immediate feedback and environmentally safe Senior Driving Simulation Training (SDST). This study aims to establish the Senior Driving Simulation Training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI), and explore the effectiveness of Senior Driving Simulation Training (SDST) on the executive function, cognitive function and EEG. The investigators intend to conduct a single-blind randomized controlled trial using a two-arm parallel-group design. Participants will be randomized by the permuted block randomization, block size of 4, into an experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) or a control group (Waiting list). The investigators plan to blind the therapists and outcome assessors to maintain the blinding methods' quality. The primary outcome indicators are mental set-shifting, working memory, and inhibition. The secondary outcome indicators are cognitive function and EEG. The investigators also evaluate visual awareness and simulator sickness. The short-term (immediate post-test) and the long-term (3, 6, and 12 months) effectiveness of the intervention on individual outcome measures will be analyzed by the generalized estimating equation. The investigators also plan to use the secondary data analysis methods to investigate the relationship between objective indicators of a driving simulator, executive function, cognitive function, EEG, visual awareness, and simulator sickness. Furthermore, the investigators will analyze the trend of EEG while the participants conducting the training, and complete the psychometric properties of the Chinese version of the Cognitive Change Index (C-CCI). This will be the first senior driving simulation training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI) in Taiwan. Results of the current study will provide valuable information on driving safety decisions and apply to promote the advanced driving policies.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjective cognitive decline( AD-8 scale ≥1 point).
  • Mild cognitive impairment (AD-8 scale ≥ 2 points), and MMSE> 24 points, can maintain personal daily activity function.
  • Can communicate in Chinese or Taiwanese.
  • At least 60 years of age.
  • Those with a car driving license.
  • No physical impairment.
  • In addition to the above conditions, participants must be voluntary and signed informed consent.

Exclusion criteria

  • Dementia, diagnosed by a physician and in compliance with ICD-10.
  • Significant mental illness or communication impairment.

Treatment and study plan

Senior Driving Simulation Training

Other

The experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) .

Waiting list control

Other

The control group is waiting list control. They will also receive the (Senior Driving Simulation Training) after all research is done.

Primary outcomes

  1. Mental set shifting, measured by Wisconsin Card Sorting Test

    Time frame: immediate post-test

    Mental set shifting is one of the sub-categories of executive function

  2. Change from Baseline Mental set shifting, measured by Wisconsin Card Sorting Test at 3 months

    Time frame: 3 months follow-up

    Mental set shifting is one of the sub-categories of executive function

  3. Working memory, measured by Digit span test

    Time frame: immediate post-test

    Working memory is one of the sub-categories of executive function

  4. Change from Baseline Working memory, measured by Digit span test at 3 months

    Time frame: 3 months follow-up

    Working memory is one of the sub-categories of executive function

  5. Inhibition, measured by the Stroop Color and Word Test

    Time frame: immediate post-test

    Inhibition is one of the sub-categories of executive function

  6. Change from Baseline Inhibition, measured by the Stroop Color and Word Test at 3 months

    Time frame: 3 months follow-up

    Inhibition is one of the sub-categories of executive function

Secondary outcomes

  1. Cognitive function measured by Montreal Cognitive Assessment

    Time frame: immediate post-test

    Cognitive function measured by Montreal Cognitive Assessment

  2. Cognitive function measured by Cognitive Change Index(C-CCI)

    Time frame: immediate post-test

    Cognitive function measured by Cognitive Change Index(C-CCI)

  3. Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months

    Time frame: 3 months follow-up

    Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months

  4. Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months

    Time frame: 3 months follow-up

    Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months

  5. EEG

    Time frame: immediate post-test

    EEG power in delta, theta, alpha, and beta band

  6. Change from Baseline EEG at 3 months

    Time frame: 3 months follow-up

    EEG power in delta, theta, alpha, and beta band

  7. Visual awareness measured by CANTAB

    Time frame: immediate post-test

    Visual awareness measured by CANTAB

  8. Visual awareness measured by trail making test

    Time frame: immediate post-test

    Visual awareness measured by trail making test

  9. Change from Baseline visual awareness by CANTAB at 3 months

    Time frame: 3 months follow-up

    Visual awareness measured by CANTAB

  10. Change from Baseline visual awareness by trail making test at 3 months

    Time frame: 3 months follow-up

    Change from Baseline visual awareness by trail making test at 3 months

  11. simulator sickness

    Time frame: immediate post-test

    Simulator Sickness Questionnaire (SSQ). The 16-item SSQ will be used to assess participants' sickness levels. This is the 4-point Likert scale (0 - "None" to 3 - "Severe"), and the higher total score reflects more severe sickness.

  12. Usability

    Time frame: immediate post-test

    The System Usability Scale (SUS) will be used to access the usability, this scale consists of 10 items, and the higher total score reflects better usability.

  13. Acceptance

    Time frame: immediate post-test

    The Technology Acceptance for Older Adults Scale will be used to access the acceptance, this scale consists of 17 items, and the higher total score reflects better acceptance.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Evaluation of Senior Driving Simulation Training on Executive Function, Cognitive Promotion and EEG in Subjective Cognitive Decline and Mild Cognitive Impairment

Acronym: SDST

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 18, 2022
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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