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Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder

Primary Purpose

REM Sleep Behavior Disorder

Status
Suspended
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tablet computer-based cognitive training program
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for REM Sleep Behavior Disorder

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 60-80 years old who have been diagnosed with iRBD through nocturnal polysomnography according to the International Classification of Sleep Disorders 3rd Edition (ICSD-3) diagnostic criteria
  • Those who gave their written consent to participate in the study

Exclusion Criteria:

  • Patients with neurodegenerative diseases including Parkinson's disease, dementia, and multiple system atrophy
  • Patients with secondary causes of RBD
  • Patients with severe hearing, visual impairment, or motor impairment
  • Patients who have received cognitive training within the last year

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

tablet group

control group

Arm Description

A total of 36 sessions per week for 12 weeks of cognitive training program using a tablet computer are performed.

Subjects assigned to the control group did not receive any separate cognitive training for 12 weeks.

Outcomes

Primary Outcome Measures

Change in Korean version of the Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet (CERAD-K) total score
Z score of total 5 domains (attentive, memory, language, visuospatial and executive functions)

Secondary Outcome Measures

Change in CERAD-K attention score
Scores for each of the 5 domains 1.Attention Trail making test A (0~360): higher scores mean a worse outcome Stroop test (word) (0~): higher scores mean a better outcome
Change in CERAD-K memory score
Scores for each of the 5 domains 2.Memory Word registration (0~30): higher scores mean a better outcome Word recall (0~10): higher scores mean a better outcome Word recognition (0~10): higher scores mean a better outcome Constructional recall (0~11): higher scores mean a better outcome
Change in CERAD-K language score
Scores for each of the 5 domains 3.Language - Boston naming test (0~15): higher scores mean a better outcome
Change in CERAD-K visuospatial function score
Scores for each of the 5 domains 4.Visuospatial function - Constructional behavior (0~11): higher scores mean a better outcome
Change in CERAD-K executive function score
Scores for each of the 5 domains 5.Executive function Trail making test B (0~300): higher scores mean a worse outcome Language fluency (0~): higher scores mean a better outcome Stroop test (word/color) (0~): higher scores mean a better outcome
Change in mini-mental status examination in the Korean version (MMSE-K) score
minimum value: 0, maximum value: 30 (higher scores mean a better outcome)
Change in Korean version of Montreal Cognitive Assessment (MoCA-K) score
minimum value: 0, maximum value: 30 (higher scores mean a better outcome)
Change in resting electroencephalography (EEG) power spectrum
distribution of power into frequency components composing the signal (delta, theta, alpha, beta)
Change in resting electroencephalography (EEG) weighted phase lag index
a functional connectivity measure that quantified how consistently 90° (or 270°) phase 'lagging' one EEG signal was compared to another (From 0 to 1, if it is close to 1, the connectivity is high)
Change in event-related potential (ERP) reaction time
time (ms) from target presentation to button press
Change in event-related potential (ERP) hit rate
the probability that an old item is either correctly recognized, or not
Change in event-related potential (ERP) N2 amplitude
The N2 peak (μV) is a fronto-central maximal negativity observed approximately 150-400 ms after stimulus onset
Change in event-related potential (ERP) time-frequency analysis
Indicates the power of the EEG frequency at a specific time

Full Information

First Posted
February 6, 2022
Last Updated
April 19, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05256836
Brief Title
Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder
Official Title
Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
Enrollment suspended
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the effectiveness of tablet computer-based cognitive training in patients with idiopathic REM sleep behavior disorder.
Detailed Description
Rapid eye movement (REM) sleep behavior disorder (RBD) is a parasomnia characterized by abnormal movement to reproduce dreams and loss of skeletal muscle tension during REM sleep. Idiopathic RBD (iRBD) refers to the absence of any predisposing factors or comorbid neurological disorders. iRBD is considered the prodromal stage of alpha-synucleinopathy. Through past studies, it has been confirmed that cognitive function decline has already occurred in a significant number of iRBD patients. However, there is still no treatment that can suppress or delay the onset of neurodegenerative diseases. The cognitive function improvement effect of computerized cognitive training in the elderly and patients with mild cognitive impairment is known. However, the effect of cognitive training on improving cognitive function in iRBD patients has not been studied. The investigators developed a program that allows patients to train cognitive functions in various domains by repeatedly performing tasks related to daily life activities. In addition, by loading the program on the tablet computer, it is possible to participate in the training easily at home using the touch screen without visiting the hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
REM Sleep Behavior Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tablet group
Arm Type
Experimental
Arm Description
A total of 36 sessions per week for 12 weeks of cognitive training program using a tablet computer are performed.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Subjects assigned to the control group did not receive any separate cognitive training for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Tablet computer-based cognitive training program
Intervention Description
The subject of the study executes a program mounted on a tablet personal computer (PC) (Samsung Galaxy Tab S6 Lite) and performs a cognitive training task by touching the screen with the index finger. It consists of 10 tasks related to the activity of daily living: 1) taking medicine, 2) making a phone call, 3) taking a shower, 4) doing laundry, 5) finding directions, 6) riding the bus, 7) buying goods, 8) Money management, 9) ingredient sorting, 10) meal preparation. It is involved in cognitive functions in various domains such as attention, working memory, processing speed, problem solving, visuospatial ability, verbal and visuospatial memory. There are three levels of difficulty for each task, high, medium, and low, and the difficulty becomes more difficult as session 1 to 36 progresses. One cognitive training session lasts about 30 minutes.
Primary Outcome Measure Information:
Title
Change in Korean version of the Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet (CERAD-K) total score
Description
Z score of total 5 domains (attentive, memory, language, visuospatial and executive functions)
Time Frame
Change from baseline CERAD-K total score at 12 weeks
Secondary Outcome Measure Information:
Title
Change in CERAD-K attention score
Description
Scores for each of the 5 domains 1.Attention Trail making test A (0~360): higher scores mean a worse outcome Stroop test (word) (0~): higher scores mean a better outcome
Time Frame
Change from baseline CERAD-K attention score at 12 weeks
Title
Change in CERAD-K memory score
Description
Scores for each of the 5 domains 2.Memory Word registration (0~30): higher scores mean a better outcome Word recall (0~10): higher scores mean a better outcome Word recognition (0~10): higher scores mean a better outcome Constructional recall (0~11): higher scores mean a better outcome
Time Frame
Change from baseline CERAD-K memory score at 12 weeks
Title
Change in CERAD-K language score
Description
Scores for each of the 5 domains 3.Language - Boston naming test (0~15): higher scores mean a better outcome
Time Frame
Change from baseline CERAD-K language score at 12 weeks
Title
Change in CERAD-K visuospatial function score
Description
Scores for each of the 5 domains 4.Visuospatial function - Constructional behavior (0~11): higher scores mean a better outcome
Time Frame
Change from baseline CERAD-K visualspatial function score at 12 weeks
Title
Change in CERAD-K executive function score
Description
Scores for each of the 5 domains 5.Executive function Trail making test B (0~300): higher scores mean a worse outcome Language fluency (0~): higher scores mean a better outcome Stroop test (word/color) (0~): higher scores mean a better outcome
Time Frame
Change from baseline CERAD-K executive function score at 12 weeks
Title
Change in mini-mental status examination in the Korean version (MMSE-K) score
Description
minimum value: 0, maximum value: 30 (higher scores mean a better outcome)
Time Frame
Change from baseline MMSE-K score at 12 weeks
Title
Change in Korean version of Montreal Cognitive Assessment (MoCA-K) score
Description
minimum value: 0, maximum value: 30 (higher scores mean a better outcome)
Time Frame
Change from baseline MoCA-K score at 12 weeks
Title
Change in resting electroencephalography (EEG) power spectrum
Description
distribution of power into frequency components composing the signal (delta, theta, alpha, beta)
Time Frame
Change from baseline EEG power spectrum at 12 weeks
Title
Change in resting electroencephalography (EEG) weighted phase lag index
Description
a functional connectivity measure that quantified how consistently 90° (or 270°) phase 'lagging' one EEG signal was compared to another (From 0 to 1, if it is close to 1, the connectivity is high)
Time Frame
Change from baseline EEG weighted phase lag index at 12 weeks
Title
Change in event-related potential (ERP) reaction time
Description
time (ms) from target presentation to button press
Time Frame
Change from baseline ERP reaction time at 12 weeks
Title
Change in event-related potential (ERP) hit rate
Description
the probability that an old item is either correctly recognized, or not
Time Frame
Change from baseline ERP hit rate at 12 weeks
Title
Change in event-related potential (ERP) N2 amplitude
Description
The N2 peak (μV) is a fronto-central maximal negativity observed approximately 150-400 ms after stimulus onset
Time Frame
Change from baseline ERP N2 amplitude at 12 weeks
Title
Change in event-related potential (ERP) time-frequency analysis
Description
Indicates the power of the EEG frequency at a specific time
Time Frame
Change from baseline ERP time-frequency analysis at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 60-80 years old who have been diagnosed with iRBD through nocturnal polysomnography according to the International Classification of Sleep Disorders 3rd Edition (ICSD-3) diagnostic criteria Those who gave their written consent to participate in the study Exclusion Criteria: Patients with neurodegenerative diseases including Parkinson's disease, dementia, and multiple system atrophy Patients with secondary causes of RBD Patients with severe hearing, visual impairment, or motor impairment Patients who have received cognitive training within the last year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-Young Jung, professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder

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