Clinical trial NCT05256836: 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
Overall status: SUSPENDED
Phase: NA
Conditions: REM Sleep Behavior Disorder
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Korean version of the Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet (CERAD-K) total score
timeFrame: Change from baseline CERAD-K total score at 12 weeks
Secondary outcomes:
measure: Change in CERAD-K attention score
timeFrame: Change from baseline CERAD-K attention score at 12 weeks
measure: Change in CERAD-K memory score
timeFrame: Change from baseline CERAD-K memory score at 12 weeks
measure: Change in CERAD-K language score
timeFrame: Change from baseline CERAD-K language score at 12 weeks
measure: Change in CERAD-K visuospatial function score
timeFrame: Change from baseline CERAD-K visualspatial function score at 12 weeks
measure: Change in CERAD-K executive function score
timeFrame: Change from baseline CERAD-K executive function score at 12 weeks
measure: Change in mini-mental status examination in the Korean version (MMSE-K) score
timeFrame: Change from baseline MMSE-K score at 12 weeks
measure: Change in Korean version of Montreal Cognitive Assessment (MoCA-K) score
timeFrame: Change from baseline MoCA-K score at 12 weeks
measure: Change in resting electroencephalography (EEG) power spectrum
timeFrame: Change from baseline EEG power spectrum at 12 weeks
measure: Change in resting electroencephalography (EEG) weighted phase lag index
timeFrame: Change from baseline EEG weighted phase lag index at 12 weeks
measure: Change in event-related potential (ERP) reaction time
timeFrame: Change from baseline ERP reaction time at 12 weeks
measure: Change in event-related potential (ERP) hit rate
timeFrame: Change from baseline ERP hit rate at 12 weeks
measure: Change in event-related potential (ERP) N2 amplitude
timeFrame: Change from baseline ERP N2 amplitude at 12 weeks
measure: Change in event-related potential (ERP) time-frequency analysis
timeFrame: Change from baseline ERP time-frequency analysis at 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ki-Young Jung, professor
role: STUDY_CHAIR
References: