REM Sleep Behavior DisorderNCT05256836
Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder
A study testing Tablet computer-based cognitive training program in people with REM Sleep Behavior Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the effectiveness of tablet computer-based cognitive training in patients with idiopathic REM sleep behavior disorder. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- REM Sleep Behavior Disorder
- What is being tested?
- Tablet computer-based cognitive training program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Feb 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
To evaluate the effectiveness of tablet computer-based cognitive training in patients with idiopathic REM sleep behavior disorder.
Read the 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.
- Conditions
- REM Sleep Behavior Disorder
- Being tested
- Tablet computer-based cognitive training program
- Medical subject headings
- REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| tablet group | Experimental | A total of 36 sessions per week for 12 weeks of cognitive training program using a tablet computer are performed. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline CERAD-K total score at 12 weeks
Secondary outcomes (13)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline CERAD-K executive function score at 12 weeks
Change in mini-mental status examination in the Korean version (MMSE-K) score
minimum value: 0, maximum value: 30 (higher scores mean a better outcome)
Measured: Change from baseline MMSE-K score at 12 weeks
Change in Korean version of Montreal Cognitive Assessment (MoCA-K) score
minimum value: 0, maximum value: 30 (higher scores mean a better outcome)
Measured: Change from baseline MoCA-K score at 12 weeks
Change in resting electroencephalography (EEG) power spectrum
distribution of power into frequency components composing the signal (delta, theta, alpha, beta)
Measured: Change from baseline EEG power spectrum at 12 weeks
Change in resting electroencephalography (EEG) weighted phase lag index
a functional connectivity measure that quantified how consistently 90° (or 270°) phase 'lagging' one EEG signal was compared to another (From 0 to 1, if it is close to 1, the connectivity is high)
Measured: Change from baseline EEG weighted phase lag index at 12 weeks
Change in event-related potential (ERP) reaction time
time (ms) from target presentation to button press
Measured: Change from baseline ERP reaction time at 12 weeks
Change in event-related potential (ERP) hit rate
the probability that an old item is either correctly recognized, or not
Measured: Change from baseline ERP hit rate at 12 weeks
Change in event-related potential (ERP) N2 amplitude
The N2 peak (μV) is a fronto-central maximal negativity observed approximately 150-400 ms after stimulus onset
Measured: Change from baseline ERP N2 amplitude at 12 weeks
Change in event-related potential (ERP) time-frequency analysis
Indicates the power of the EEG frequency at a specific time
Measured: Change from baseline ERP time-frequency analysis at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start7 Feb 2022
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Enrollment suspended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ki-Young Jung, professor, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256836
- Sponsor's protocol ID
- 2105-117-1220
- Status last verified
- Apr 2023
- First submitted
- 6 Feb 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT05256836
- Acronym / sponsor ID
- 2105-117-1220
- Conditions
- REM Sleep Behavior Disorder
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Enrollment suspended
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tablet group | Experimental | Other: Tablet computer-based cognitive training programA total of 36 sessions per week for 12 weeks of cognitive training program using a tablet computer are performed. |
| control group | No intervention | –Subjects assigned to the control group did not receive any separate cognitive training for 12 weeks. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet computer-based cognitive training programThe 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. | Other | tablet group |
Primary outcome
Change in Korean version of the Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet (CERAD-K) total score
Time frame: Change from baseline CERAD-K total score at 12 weeks
Z score of total 5 domains (attentive, memory, language, visuospatial and executive functions)
13 secondary outcomes
Change in CERAD-K attention score
Time frame: Change from baseline CERAD-K attention score at 12 weeks
Change in CERAD-K memory score
Time frame: Change from baseline CERAD-K memory score at 12 weeks
Change in CERAD-K language score
Time frame: Change from baseline CERAD-K language score at 12 weeks
Change in CERAD-K visuospatial function score
Time frame: Change from baseline CERAD-K visualspatial function score at 12 weeks
Change in CERAD-K executive function score
Time frame: Change from baseline CERAD-K executive function score at 12 weeks
Change in mini-mental status examination in the Korean version (MMSE-K) score
Time frame: Change from baseline MMSE-K score at 12 weeks
Change in Korean version of Montreal Cognitive Assessment (MoCA-K) score
Time frame: Change from baseline MoCA-K score at 12 weeks
Change in resting electroencephalography (EEG) power spectrum
Time frame: Change from baseline EEG power spectrum at 12 weeks
Change in resting electroencephalography (EEG) weighted phase lag index
Time frame: Change from baseline EEG weighted phase lag index at 12 weeks
Change in event-related potential (ERP) reaction time
Time frame: Change from baseline ERP reaction time at 12 weeks
Change in event-related potential (ERP) hit rate
Time frame: Change from baseline ERP hit rate at 12 weeks
Change in event-related potential (ERP) N2 amplitude
Time frame: Change from baseline ERP N2 amplitude at 12 weeks
Change in event-related potential (ERP) time-frequency analysis
Time frame: Change from baseline ERP time-frequency analysis at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki-Young Jung, professor study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet computer-based cognitive training program in people with REM Sleep Behavior Disorder, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Korean version of the Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet (CERAD-K) total score (time frame: Change from baseline CERAD-K total score at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.