The aim of this study is to explore the effects of the dual orexin receptor antagonist Lemborexant on improving motor and sleep comorbidity in patients with Parkinson's disease. This study will provide clinical evidence for the application of dual orexin receptor antagonists in the treatment of Parkinson's Disease.
Parkinson's disease (PD) is the most common movement disorder. Its core motor symptoms include bradykinesia, resting tremor, muscle rigidity, and postural instability. Furthermore, patients frequently experience severe non-motor symptoms, such as sleep disorders and mood/affective disturbances. Among these, sleep disorders, especially insomnia, are one of the most prevalent non-motor symptoms. They are often overlooked in clinical management. The axons of central orexin neurons project extensively throughout the brain, encompassing key regions such as motor control centers and sleep-wake regulation centers. During the pathological process of PD, dysfunctional orexin neurons may contribute to the disruption of both motor and sleep functions by modulating these target areas. By recruiting PD patients with comorbid motor and insomnia symptoms, the investigators will investigate the efficacy of Lemborexant in treating both motor and sleep disturbances in PD patients. With its advantages of target specificity, established safety, and a lower side-effect profile compared to traditional hypnotics, Lemborexant holds promise as a novel therapeutic intervention for Parkinson's disease. This research may offer new possibilities for expanding clinical treatment strategies for PD. Participants will take 5 mg medication (or placebo) each night for 28 days and be asked to come for 4 times study visits (Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up). The major experiment contents include: 1. To evaluate the effect of oral Lemborexant on Parkinson's disease motor symptoms in participants (using the Unified Parkinson's Disease Rating Scale, UPDRS); 2. To evaluate the effect of oral Lemborexant on the sleep quality of participants (using the Parkinson's Disease Sleep Scale (PDSS), the Insomnia Severity Index (ISI), the Pittsburgh Sleep Quality Index (PSQI)).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
Participants will receive oral Lemborexant (5 mg/day) nightly approximately 5-30 minutes before going to bed for 28 consecutive days.
Participants will receive a matching placebo nightly approximately 5-30 minutes before going to bed for 28 consecutive days.
Changes in the scores of Part III of the Unified Parkinson's Disease Rating Scale (UPDRS)
The scores of Part III of the UPDRS (motor examination) score will be collected from each participant to measure the severity of motor ability with scores ranging from 0 (minimum) to 108 (maximum). The higher scores mean a worse outcome.
Time frame: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.
Changes in the scores of the Parkinson's Disease Sleep Scale (PDSS)
PDSS is used to quantify the severity of sleep problems associated with Parkinson's disease. Its score ranges from 0 (minimum) to 150 (maximum), with lower scores indicating more severe sleep disturbances. Typically, a total score below 90 is considered indicative of a clinically significant sleep disorder.
Time frame: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.
Changes in the scores of Part II of the Unified Parkinson's Disease Rating Scale (UPDRS)
The scores of Part II of the UPDRS (daily living activities) score will be collected from each participant to measure the severity of daily living activities with scores ranging from 0 (minimum) to 52 (maximum). The higher scores mean a worse outcome.
Time frame: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.
Changes in the scores of the Insomnia Severity Index (ISI)
ISI is used to screen for and assess the severity of insomnia. Its score ranges from 0 (minimum) to 28 (maximum), with higher scores indicating more severe sleep problems. A total score of 10 or above suggests the presence of clinically significant insomnia.
Time frame: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.
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Changes in the scores of the Pittsburgh Sleep Quality Index (PSQI)
PSQI is used to comprehensively evaluate multiple aspects of sleep quality. Its score ranges from 0 (minimum) to 21 (maximum), with higher scores indicating poorer sleep quality. A total score greater than 5 is generally considered to indicate poor sleep quality.
Time frame: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.