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

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Seoul National University

Status

Suspended

Conditions

REM Sleep Behavior Disorder

Treatments

Other: Tablet computer-based cognitive training program

Study type

Interventional

Funder types

Other

Identifiers

NCT05256836
2105-117-1220

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

60 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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