This single-center, randomized, single-blind, sham-controlled clinical trial aims to evaluate whether remote ischemic conditioning (RIC) can improve sleep disturbances and other non-motor symptoms in patients with Parkinson's disease (PD). Forty-eight PD patients with insomnia will be randomly assigned in a 1:1 ratio to receive either active RIC (cuff inflation to high pressure) or sham RIC (cuff inflation to low pressure) for 7 consecutive days, in addition to their standard antiparkinsonian medications. Subjective sleep scales, sleep diaries, validated rating scales for motor and non-motor symptoms, and overnight polysomnography will be used to assess treatment effects at baseline, after the 7-day intervention, and during short-term follow-up. The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers.
Diagnosis of Parkinson's disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
Age between 50 and 70 years.
Disease duration ≤ 5 years.
Hoehn and Yahr stage I-III in the "on" state.
Secondary insomnia due to other severe medical conditions (e.g., uncontrolled cardiopulmonary, hepatic, renal, or endocrine diseases).
Current psychotic symptoms or severe anxiety or depression (e.g., Hamilton Anxiety Scale score ≥ 14 or Hamilton Depression Scale score ≥ 17).
Other primary sleep disorders such as moderate-to-severe obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder, or rapid eye movement sleep behavior disorder that require specific treatment.
History of significant cerebrovascular disease, brain tumor, central nervous system infection, or other neurological disorders that may interfere with sleep or study assessments.
Parallel
Remote ischemic conditioning device
DeviceAn automated upper-limb cuff device is applied to one arm to induce brief episodes of limb ischemia and reperfusion. In the active RIC group, the cuff is inflated to a high pressure (approximately 200 mmHg) sufficient to occlude arterial blood flow, and then deflated repeatedly according to a pre-set program recommended by the manufacturer. RIC is performed twice daily for 7 consecutive days.
Sham remote ischemic conditioning
DeviceThe same device and procedure are used as in the active RIC group, but the cuff is inflated only to a low pressure (approximately 60 mmHg) that does not occlude arterial blood flow. Sham RIC is performed twice daily for 7 consecutive days.
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score
The PDSS-2 is a 15-item patient-reported questionnaire assessing sleep problems in Parkinson's disease. Total scores range from 0 to 60, with higher scores indicating more severe sleep disturbances. The primary outcome is the change in PDSS-2 total score from baseline to the end of the 7-day RIC or sham RIC intervention.
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (0-260 points; higher scores indicate worse motor and non-motor symptoms).
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is used to assess motor and non-motor symptoms in Parkinson's disease. The total score ranges from 0 to 260 points, with higher scores indicating more severe impairment. The outcome measure is the change in MDS-UPDRS total score from baseline to 7 days after remote ischemic conditioning (RIC).
Change in Montreal Cognitive Assessment (MoCA) total score (0-30 points; higher scores indicate better cognitive function).
The Montreal Cognitive Assessment (MoCA) is a 30-point screening instrument for global cognitive function. Total scores range from 0 to 30 points, with higher scores indicating better cognition. The outcome measure is the change in MoCA total score from baseline to 7 days after remote ischemic conditioning (RIC).
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