Parkinson Disease, Sleep Disorders
Conditions
Keywords
Stalevo, sleep disturbance, central circadian clock, narcolepsy
Brief summary
The purpose of this study is to investigate the genetic variants of clock and narcolepsy genes that determine the therapeutic effects of Stalevo® on the quality of sleep in patients with Parkinson's Disease.
Interventions
DRUGStalevo®
* Sleep disorders in Parkinson's disease * Analysis by Parkinson's Disease Sleep Scale(PDSS) scores. * If the PDSS score is improving at least 15 percent than the baseline score, It can be determined to be effective.
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with PD in accordance with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (Hughes AJ, et al. 1992). 2. Patients with PD who have wearing off phenomenon. 3. Patients with PD with Hoehn and Yahr stage 1-4. 4. Patients with PD who have sleep problems (PDSS score ≤120 or Epworth Sleepiness Scale(ESS) score ≥ 8). 5. Patients with PD who showed Montreal Cognitive Assessment (MoCA) score ≥15. 6. Patients with PD who have no major depression (Geriatric depression scale, GDS ≤ 24)
Exclusion criteria
1. Secondary parkinsonism 2. Parkinson-plus syndromes (multiple system atrophy, progressive supranuclear palsy, and corticobasal degeneration. 3. Patients with PD who have history of severe side effect of Stalevo®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The correlation of the genetic variants of central circadian clock and narcolepsy genes with regard to the treatment effect of Stalevo® in sleep disturbance of parkinson's disease. | 2 years | To determine whether the genetic variants of clock and narcolepsy genes are associated with the effectiveness of Stalevo® in bedtime on the quality of sleep in PD patients with motor fluctuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effectiveness of Stalevo® in bedtime on the quality of sleep in PD patients with motor fluctuation (using Parkinson's Disease Sleep Scale) | up to 3 months from enrollment. | To determine whether Stalevo® in bedtime improves the quality of sleep in PD patients with motor fluctuation using Parkinson's Disease Sleep Scale. |
| The effectiveness about improving the EDS(Excessive daytime sleepiness) in PD patients with motor fluctuation after taking Stalevo® in bedtime. | up to 3 months from enrollment. | Excessive daytime sleepiness (EDS) is characterized by persistent sleepiness and often a general lack of energy, even after apparently adequate or even prolonged night time sleep. EDS can be considered as one of features of sleep disturbance in parkinson's disease. It will be assessed using a composite measurement consisting of Unified Parkinson's Disease Rating Scale (UPDRS), Hoehn and Yahr stage, Parkinson's Disease Sleep Scale (PDSS), Epworth Sleepiness Scale (ESS), Parkinson's Disease Wearing Off Questionnaire-9 (PDWOQ-9), and Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39). |
| The effectiveness about improving the morning motor symptoms in PD patients with motor fluctuation after taking Stalevo® in bedtime. | up to 3 months from enrollment | To determine whether Stalevo® in bedtime improves the morning motor symptoms in PD patients with motor fluctuation. It will be assessed using a composite measurement consisting of Unified Parkinson's Disease Rating Scale (UPDRS), Hoehn and Yahr stage, Parkinson's Disease Sleep Scale (PDSS), Epworth Sleepiness Scale (ESS), Parkinson's Disease Wearing Off Questionnaire-9 (PDWOQ-9), and Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39). |
Countries
South Korea
Contacts
Primary ContactSun Ju Chung, Professor
Outcome results
None listed