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

NCT05256836 | Suspended DMC

• 1 other identifier: 2105-117-1220
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

REM Sleep Behavior Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in CERAD-K attention score

  Change from baseline CERAD-K attention score at 12 weeks

• Change in CERAD-K memory score

  Change from baseline CERAD-K memory score at 12 weeks

• Change in CERAD-K language score

  Change from baseline CERAD-K language score at 12 weeks

• Change in CERAD-K visuospatial function score

  Change from baseline CERAD-K visualspatial function score at 12 weeks

• Change in CERAD-K executive function score

  Change from baseline CERAD-K executive function score at 12 weeks

Study Arms (2)

tablet group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

Tablet computer-based cognitive training program 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.

tablet group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ki-Young Jung, professor

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: February 25, 2022
• Study Start: February 7, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

KR (1)