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

Seoul National University Hospital60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

REM Sleep Behavior Disorder

Interventions

Tablet computer-based cognitive training programOTHER

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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)

Time frame: Change from baseline CERAD-K total score at 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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