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

NCT ID: NCT05256836

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-07

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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REM Sleep Behavior Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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tablet group

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

Group Type EXPERIMENTAL

Tablet computer-based cognitive training program

Intervention Type OTHER

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.

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ki-Young Jung, professor

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2105-117-1220

Identifier Type: -

Identifier Source: org_study_id

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