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

To evaluate the effectiveness of tablet computer-based cognitive training in patients with idiopathic REM sleep behavior disorder.

Study Overview

• Status: Suspended
• Conditions: REM Sleep Behavior Disorder
• Intervention / Treatment: Other: Tablet computer-based cognitive training program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tablet group; A total of 36 sessions per week for 12 weeks of cognitive training program using a tablet computer are performed.	Other: Tablet computer-based cognitive training program; 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.
No Intervention: control group; Subjects assigned to the control group did not receive any separate cognitive training for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Change from baseline CERAD-K total score at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 from baseline CERAD-K attention score at 12 weeks
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 from baseline CERAD-K memory score at 12 weeks
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 from baseline CERAD-K language score at 12 weeks
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 from baseline CERAD-K visualspatial function score at 12 weeks
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 from baseline CERAD-K executive function score at 12 weeks
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 from baseline MMSE-K score at 12 weeks
Change in Korean version of Montreal Cognitive Assessment (MoCA-K) score	minimum value: 0, maximum value: 30 (higher scores mean a better outcome)	Change from baseline MoCA-K score at 12 weeks
Change in resting electroencephalography (EEG) power spectrum	distribution of power into frequency components composing the signal (delta, theta, alpha, beta)	Change from baseline EEG power spectrum at 12 weeks
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 from baseline EEG weighted phase lag index at 12 weeks
Change in event-related potential (ERP) reaction time	time (ms) from target presentation to button press	Change from baseline ERP reaction time at 12 weeks
Change in event-related potential (ERP) hit rate	the probability that an old item is either correctly recognized, or not	Change from baseline ERP hit rate at 12 weeks
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 from baseline ERP N2 amplitude at 12 weeks
Change in event-related potential (ERP) time-frequency analysis	Indicates the power of the EEG frequency at a specific time	Change from baseline ERP time-frequency analysis at 12 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Ki-Young Jung, professor, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 6, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Sleep Wake Disorders; Parasomnias; REM Sleep Parasomnias; Mental Disorders; REM Sleep Behavior Disorder
• Other Study ID Numbers: 2105-117-1220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No