Parkinson's Disease Sleep Scale Research Articles

Effects of dopaminergic therapy on sleep quality in fluctuating Parkinson's disease patients.

Sleep disorders negatively impact quality of life in Parkinson's disease (PD), yet the role of antiparkinsonian drugs on sleep quality is still unclear. We aimed to explore the correlation between sleep dysfunction and dopaminergic therapy in a large cohort of advanced PD patients. Patients consecutively evaluated for device-aided therapies eligibility were evaluated by means of the PD Sleep Scale (PDSS-2; score ≥ 18 indicates poor sleep quality), and the Epworth Sleepiness Scale (ESS score ≥ 10 indicates excessive daytime sleepiness-EDS). Binary logistic regression analysis, adjusting for age, sex, disease duration, motor impairment, and sleep drugs, was employed to evaluate the association between dopaminergic therapy and PDSS-2 and ESS scores. Analysis of covariance assessed differences in PDSS-2 and ESS scores between patients without DA, and between patients treated with low or high doses of DA (cut-off: DA-LEDD = 180mg). In a cohort of 281 patients, 66.2% reported poor sleep quality, and 34.5% reported EDS. DA treatment demonstrated twofold lower odds of reporting relevant sleep disturbances (OR 0.498; p = 0.035), while DA-LEDD, levodopa-LEDD, total LEDD, and extended-release levodopa were not associated with disturbed sleep. EDS was not influenced by dopaminergic therapy. Patients with DA intake reported significant lower PDSS-2 total score (p = 0.027) and "motor symptoms at night" domain score (p = 0.044). Patients with higher doses of DA showed lower PDSS-2 total score (p = 0.043). Our study highlights the positive influence of DA add-on treatment on sleep quality in this group of advanced fluctuating PD patients.

Association of intestinal inflammation and permeability markers with clinical manifestations of Parkinson's disease

IntroductionIntestinal inflammation and gut microbiota dysbiosis can stimulate degeneration of dopaminergic neurons and development of Parkinson's disease (PD) via the gut-brain axis in certain patients. MethodsIn a case-control study, fecal markers of intestinal inflammation and permeability were measured using the ELISA method in PD patients and healthy controls. Motor and nonmotor symptoms were assessed using the Movement Disorder Society (MDS) Unified PD Rating Scale, Hoehn & Yahr scale, MDS Non-Motor Symptom Scale, Scales for Outcomes in PD - Autonomic Dysfunction, PD Sleep Scale - 2, Montreal Cognitive Assessment, Beck Anxiety Inventory, and Beck Depression Inventory-II. A correlation was established between the intestinal inflammation and permeability markers and PD symptoms. ResultsHigher levels of beta-defensin 2, zonulin and lactoferrin were recorded in PD patients compared to controls. Calprotectin and secretory immunoglobulin A showed no significant differences. Regression analysis indicated the roles of beta-defensin 2 and lactoferrin in predicting PD likelihood. Calprotectin yielded positive correlations with disease duration, depression, motor fluctuations, and gastrointestinal symptoms; beta defensin 2 with thermoregulation; and secretory immunoglobulin A with depression. Secretory immunoglobulin A showed negative correlation with age and age at disease onset, while zonulin showed negative correlation with the MDS Unified PD Rating Scale total score. ConclusionsFecal markers differed in PD patients compared to controls and correlated with age, disease duration, and some nonmotor symptoms. Future studies should identify the subgroups of PD patients that are likely to develop intestinal inflammation.

Assessment of sleep disturbance in patients with Wilson’s disease

BackgroundWilson’s disease (WD) is frequently manifested with anxiety, depression and sleep disturbance; this investigation aimed to elucidate these manifestations and identify the influencing factors of sleep disturbance.MethodsSleep disturbance, anxiety and depression were compared in 42 WD and 40 age- and gender-matched healthy individuals. 27 individuals indicated a neurological form of the disease (NV), and 15 had a non-neurological variant (NNV).ResultsThis investigation revealed that the Parkinson’s disease sleep scale (PDSS) score of WD individuals was lower, whereas their Epworth Sleepiness Scale (ESS), Pittsburgh sleep quality index (PSQI), Hamilton Anxiety Scale (HAMA), and Hamilton Depression Scale (HAMD) scores were higher than the healthy individuals (p < 0.05). Furthermore, the WD subjects had markedly increased prevalence of poor sleep quality, anxiety, and depression than healthy individuals (p < 0.05). Subgroup analysis showed that NV subjects had significantly higher scores on the UWDRS, PSQI, HAMA, and HAMD scales than those in the NV group, as well as higher rates of EDS, anxiety, and depression (p < 0.05). In patients with sleep disturbance, we identified UWDRS, neurological variant, and depression as associated factors. The linear regression model demonstrated depression as the dominant risk factor.ConclusionsDepression is highly correlated with and is a determinant of sleep disturbance in WD patients.

Improved Sleep Correlates with Improved Quality of Life and Motor Symptoms with Foslevodopa/Foscarbidopa.

Foslevodopa/foscarbidopa is a subcutaneous infusion of levodopa/carbidopa prodrugs. Assess correlations between sleep and efficacy from interim data of a phase 3 trial of foslevodopa/foscarbidopa (NCT03781167). Pearson correlations between sleep (Parkinson's Disease Sleep Scale-2 [PDSS-2]) and quality of life (QoL; Parkinson's Disease Questionnaire-39), motor experiences of daily living (m-EDL; Movement Disorder Society-Unified Parkinson's Disease Scale Part II), and "Off"/"On" times were calculated for baseline and week 26 improvements. Regression analyses were adjusted for baseline PDSS-2 score. Baseline sleep correlated moderately with QoL (r = 0.44, P < 0.001) and weakly with m-EDL (r = 0.28; P < 0.001). Sleep improvement weakly correlated with improved "Off" time (r = 0.37; P < 0.001) and QoL (r = 0.36; P < 0.001). Regression analyses demonstrated significant positive associations for improved sleep, "Off" time, QoL, and m-EDL. Improved sleep with foslevodopa/foscarbidopa was associated with improved QoL and "Off" time.

Assessment of Psychometric Characteristics of Parkinson's Disease Sleep Scale 2 and Analysis of a Cut-Off Score for Detecting Insomnia in Italian Patients with Parkinson's Disease: A Validation Study.

Sleep disorders are frequent non-motor symptoms affecting patients with Parkinson's disease (PD). Insomnia represents the most common sleep disorder. Parkinson's disease Sleep Scale 2 (PDSS-2) is a specific tool to investigate sleep problems in PD. The General Sleep Disturbances Scale (GSDS) was a general scale validated for the Italian population. Our goal was to assess the psychometric characteristics of PDSS-2 and the GSDS in this population, calculating a cut-off score for insomnia symptoms by using subitems of PDSS-2. Patients admitted at the PD Unit of the Hospital of Rome Tor Vergata outpatient clinic and those afferent to PD associations were asked to complete PDSS-2 and GSDS to be correlated to identify a cut-off for insomnia symptoms. Items 1,2,3,8,13 of PDSS-2 were used to detect insomnia. An ROC curve to assess a cut-off score for insomnia was determined. A cross-cultural analysis of PD population characteristics was performed. In total, 350 PD patients were recruited. Cronbach's alpha was high for the total score (0.828 for PDSS-2 and 0.832 for GSDS). A cross-cultural analysis did not show any significant p-value. The ROC curve yielded an AUC of 0.79 (CI: 0.75-0.84). The cut-off value for insomnia disorder based on items 1,2,3,8,13 of PDSS-2 was >10, demonstrating a sensitivity of 76% and a specificity of 69% in determining the presence of subjective insomnia symptoms in PD. PDSS-2 is demonstrated to be a valid, specific tool to address sleep disturbances in PD patients. A cut-off score of 10 for items 1,2,3,8,13 was identified for detecting insomnia symptoms in PD patients.

Non-Motor Symptom Management: Insights into Adherence to Treatment Guidelines in Parkinson's Disease Patients.

Non-motor symptoms (NMS) reduce quality of life in Parkinson's disease (PD) patients, who experience three times more NMS than individuals without PD. While there are international and national NMS treatment guidelines, their implication in clinical practice remains unclear. This study aimed to investigate the adherence to pharmacological NMS treatment guidelines in patients with mild to moderately severe PD. 220 PD patients with ≥1 NMS based on the Non-Motor Symptom Questionnaire and a Hoehn and Yahr stage ≤4 were randomly selected from the Swedish Parkinson registry and screened for inclusion. NMS were evaluated using the International Parkinson and Movement Disorder Society-Non-Motor Rating Scale (MDS-NMS), Parkinson's Disease Sleep Scale 2, Epworth Sleepiness Scale, and Hospital Anxiety and Depression Scale. Treatment was compared with Swedish national guidelines and international guidelines from the MDS Evidence-Based Medicine Committee. Among 165 included patients, the median number of NMS was 14, and in median 7 symptoms were estimated to require treatment. The most common NMS requiring treatment were pain (69%) and urinary problems (56%). Treatment of depression and constipation demonstrated the highest adherence to guidelines (79% and 77%), while dysphagia and excessive daytime sleepiness exhibited the lowest adherence (0% and 4%). On average, only 32% of NMS were treated in accordance with guidelines. Adherence to pharmacological guidelines for NMS in patients with mild to severe PD was low. This study highlights the need for improved evaluation and treatment of NMS to enhance symptom management and quality of life among PD patients.

Sleep quality, excessive daytime sleepiness, and depression in Parkinson’s disease: implications for improved patient outcomes

ABSTRACT Objectives Sleep disorders are frequently encountered non-motor symptoms that significantly impact the lifestyle quality of individuals with Parkinson’s disease (PD). Our research endeavors to research the sleep quality of PD patients and define the occurrence of excessive daytime sleepiness (EDS) and nocturnal difficulties within this population. Methods We incorporated 140 patients diagnosed with PD and 75 healthy individuals as controls. The modified Hoehn & Yahr Staging Scale (HYS) was employed for the clinical classification of PD stages, while the evaluation of clinical intensity utilized the Unified Parkinson’s Disease Rating Scale (UPDRS). The assessment of sleep quality utilized the Pittsburgh Sleep Quality Index (PSQI), along with the Parkinson’s Disease Sleep Scale (PDSS), and the Epworth Sleepiness Scale (ESS). Additionally, the subjective depression levels of attendees were assessed by the Beck Depression Inventory. Results In contrast to the healthy controls, the patient cohort demonstrated notably higher scores across the PSQI scale, ESS, and Beck Depression Scale (p < 0.05). Within the PD patient group, 66.4% exhibited poor sleep quality, and 17.1% reported excessive daytime sleepiness. A significant positive correlation was between poor sleep quality and factors such as H&Y stage, duration of levodopa exposure, scores on the ESS, and the BDI (p < 0.05). Additionally, EDS was positively correlated with UPDRS-I scores, Levodopa equivalent daily dose, PSQI, and BDI scores (p < 0.05). Discussion Addressing the specific etiology of sleep disorders in Parkinson’s patients has the potential to result in improved treatment outcomes and enhanced functionality in their daily lives.

Acupuncture and sleep disorders in Parkinson's disease: A systematic evaluation with meta-analysis.

Parkinson's disease (PD) patients commonly suffer from sleep disorders, significantly impacting their quality of life. Western treatments often entail adverse effects, while acupuncture (ACU) presents a safe, nonaddictive alternative. A thorough literature search was performed across PubMed, Cochrane Library, and Embase databases. Eligible studies underwent statistical analysis via RevMan 5.4 software. This study synthesized data from 19 randomized controlled trials involving 1300 patients. The ACU cohort showed notable improvement in Parkinson's disease sleep scale (PDSS) scores (mean difference [MD] = 10.81, 95% confidence interval [CI]: 5.64, 15.98) relative to controls. Subgroup analysis revealed significance for ACU treatments beyond 6 weeks (MD = 15.39, 95% CI: 11.70, 19.09) but not for those 6 weeks or shorter (MD = 3.51, 95% CI: -1.20, 8.23). Notably, electroacupuncture resulted in significant PDSS score enhancements (MD = 12.39, 95% CI: 6.06, 18.71), with sensitivity analysis verifying result stability. However, without electroacupuncture, PDSS score differences were insignificant (MD = 7.83, 95% CI: -2.33, 17.99) and had lower result stability. Additionally, increased ACU session frequency may yield better improvements in PDSS scores. The ACU group also observed Improved Pittsburgh Sleep Quality Index scores (MD = -4.52, 95% CI: -6.36, -2.67). However, no significant variation was identified in Epworth Sleepiness Scale score improvement between groups (MD = -0.90, 95% CI: -3.67, 1.88). ACU therapy effectively improves nighttime sleep quality in PD patients. A treatment duration extending beyond 6 weeks is highly recommended. Additionally, increasing the frequency of ACU sessions and incorporating electroacupuncture in the treatment regimen may be essential for optimal results.

The efficacy and safety of MARS-PD: Meridian activation remedy system for Parkinson's disease-A single-center, assessor and statistician-blinded, parallel-group randomized, controlled trial protocol.

Parkinson's disease (PD) patients face a substantial unmet need for disease-modifying interventions. Potential approaches such as exercise and acupuncture have been investigated to slow PD progression. To address this unmet need, we developed a novel therapeutic approach that integrates acupuncture and exercise: the Meridian Activation Remedy System for PD patients (MARS-PD). Building upon promising outcomes observed in our preliminary pilot study, where MARS-PD exhibited a large clinically important difference on the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III), we embark on a randomized controlled trial with the primary objective of examining the efficacy, safety, and economic impact of MARS-PD. In this single-center, assessor and statistician-blinded, parallel-group randomized controlled trial, we aim to investigate the clinical efficacy of MARS-PD through 16 interventions administered over 8 weeks in 88 PD patients. Participants will be randomly assigned to the experimental (n = 44) or control (n = 44) groups. The experimental group will receive MARS-PD intervention alongside standard care, while the control group will solely receive standard care. The intervention period spans 8 weeks, followed by a 12-week post-intervention follow-up. The primary endpoint is the change in MDS-UPDRS Part III score from baseline to the conclusion of the 8-week intervention. Secondary outcomes encompass various assessments, including MDS-UPDRS, International Physical Activity Questionnaire Short Form, Parkinson Self Questionnaire, Parkinson's Disease Sleep Scale, Timed Up and Go test, GAITRite metrics, Functional Near-Infrared Spectroscopy measurements, smart band outcomes, gut microbiome analysis results, and iris connective tissue texture. Previous studies by the authors have indicated MARS-PD's safety and benefits for PD patients. Building upon this foundation, our current study aims to provide a more comprehensive and detailed confirmation of the efficacy of MARS-PD. cris.nih.go.kr KCT0006646 -First posted on 7 October 2021; ClinicalTrials.gov NCT05621772 -First posted on 11 November 2022.

Effects of acupuncture on sleep quality in patients with Parkinson's disease: A systematic review and meta-analysis

Objective To systematically evaluate the evidence relating to acupuncture on the sleep quality of patients with Parkinson's disease. Data sources Six English-language (PubMed, Cochrane Library, EBSCOhost, Embase, OVID MEDLINE, and Web of Science) and four Chinese-language (China National Knowledge Infrastructure, SinoMed, China Scientific Journals Database, and Wanfang) databases were searched for pertinent studies published from database inception to 11 October 2023. Methods Two researchers independently screened eligible studies and extracted relevant data using custom data extraction tables. Methodological quality assessment of the included studies was performed using Cochrane Handbook 5.1.0. Meta-analysis was performed using Cochrane Review Manager version 5.4. Results Twenty-four studies (1701 participants) met inclusion criteria. The meta-analysis showed that acupuncture improved the Parkinson's Disease Sleep Scale, Pittsburgh Sleep Quality Index, Hamilton Anxiety Scale, Hamilton Depression Scale, Self-Rating Depression Scale, and Parkinson's Disease Questionnaire 39 scores compared with controls (all P < 0.05). Conclusion This review showed that acupuncture improved sleep quality, anxiety and depressive symptoms, and quality of life of patients with Parkinson's disease relative to controls.

Relationship Between Sleep Quality and Constipation Severity in Patients With Parkinson Disease: A Cross-sectional Study.

BACKGROUND: Constipation in patients with Parkinson disease (PD) adversely affects motor symptoms, making defecation management critical. Sleep disturbance is another common complaint in patients with PD (PWP). Associations between sleep disturbances and constipation have been reported in recent studies on PD. If improving sleep quality is useful for managing constipation in PWP, it might serve as a new method of constipation management that is less physically and mentally distressing than laxatives. This study aimed to examine the relationship between sleep quality and constipation severity in PWP. METHODS: We administered a questionnaire on sleep and constipation to 1048 PWP. Constipation severity was assessed using Constipation Assessment Scale Japanese version 2 (CAS). General sleep quality was estimated using the Japanese versions of the Pittsburgh Sleep Quality Index (PSQI) and Athens Insomnia Scale. Sleep quality due to PD-specific nighttime problems was estimated using the Parkinson's Disease Sleep Scale-2 Japanese version (PDSS-2). We conducted a multiple regression analysis using the forced entry method to identify the variables that influenced CAS. RESULTS: We analyzed 350 PWP. Overall, 94.9% of PWP had constipation symptoms. The percentages of PWP with poor sleep were as follows: PSQI, 74.7%; Athens Insomnia Scale, 69.8%; and PDSS-2, 73.8%. Furthermore, 17.6% of the patients with constipation and 35.3% with sleep problems did not consult a healthcare provider. Multivariate analysis revealed that CAS was significantly associated only with PDSS-2 (standardized partial regression coefficient, 0.217; 95% confidence interval, 0.030-0.111). CONCLUSION: Poor sleep quality, related to PD-specific nighttime problems, was found be associated with worsening constipation severity. Nursing activities that help PWP with PD-specific nighttime problems have a more comfortable night's sleep would be key to alleviating constipation severity.

A Longitudinal Two-Armed Randomized Controlled Trial Protocol to Evaluate the Efficacy of Yoga on Progression of Disease in Early Parkinson’s Disease

Background Numerous studies have shown that yoga can aid patients with Parkinson’s disease (PD) in managing their motor function, functional mobility, balance, anxiety, and overall quality of life. However, most of the reported research either needed more power or evaluated the results during or after the intervention. Due to the long-standing nature of PD, there are still few longitudinal studies investigating the potential of yoga to decrease the progression of the disease. Purpose We study whether sustained adjunct yoga intervention slows PD progression. Methods Over 18 months, this study will investigate the long-term benefits of yoga-based intervention in Parkinson’s patients. The concept of “intention-to-treat (ITT)” will be employed. From the outpatient clinic of the Swami Vivekananda Yoga Anusandhana Samsthana in India, 160 patients with PD will be chosen. They will then be randomly assigned to either the interventional or control groups (1:1). The adjunct intervention group will participate in 21 daily contact yoga sessions (60 min) at the University Medical Center, followed by continued tele-supervised home practice and at-home self-practice. The effectiveness of the adjunct intervention will be evaluated at four different time points (baseline, 3-, 9-, 12-, and 18-month post-randomization). The primary endpoint will be the difference in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at baseline and after 18 months of intervention. Secondary outcomes will include subscores of MDS-UPDRS I, II, and IV, Parkinson’s Disease Questionnaire (PDQ)-39 scores, treatment adherence, the PDQ-39, the Depression, Anxiety, and Stress Scale-21, and the Scales for Outcomes in PD-Sleep Scale (SCOPA-S). The primary outcome will be analyzed using mixed-effect models for repeated measures, adjusted for covariates as fixed effects. Results The protocol was conceptualized in October 2021 and approved by the Institutional Ethics Committee of SVYASA. Recruitment began in February 2022 and is underway with patient enrollment. Conclusion To our knowledge, this is the first controlled study to examine the long-term effects of yoga as an adjuvant therapy on the progression of PD. Key message This would be the first long-term trial to assess the potential of an adjunct yoga intervention to modulate disease progression in early Parkinson’s patients.

Association between falls and nonmotor symptoms in patients with Parkinson's disease

IntroductionParkinson's disease (PD) is a chronic neurodegenerative disorder. Falls are common in patients with PD and can lead to disability, bedridden status, and death. The mechanisms of falls induced by symptoms of PD have not been fully clarified. We investigated the association between falls and nonmotor symptoms in PD patients. MethodsA total of 361 patients with Parkinson's disease were included. Whether the patients had fallen in the past half a year was recorded. Nonmotor symptoms were assessed by 30 items from the nonmotor symptom questionnaire (NMS Quest), Parkinson's Disease Sleep Scale (PDSS), Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), and Montreal Cognitive Assessment Scale (MOCA). ResultsA total of 63 patients experienced falls in the past six months, with an incidence of 17.5%. The patients with falls were elderly, had severe motor symptoms and disease severity, and the proportion of diabetic patients who experienced falls was higher. Adjusted for the above factors, the results showed that patients with falls had higher PD-NMS, HAMD and HAMA scores, but there was no significant difference in the total score and subscores of the MoCA scale between the two groups. The risk factors related to falling included age, history of diabetes, depression (HAMD), HAMD cognitive impairment, NMS urinary tract and NMS postural hypotension. ConclusionsFalls were a common symptom in patients with PD and were not only related to motor symptoms but also closely related to nonmotor symptoms. urinary tract symptoms, postural hypotension, depression and HAMD cognitive impairment were risk factors related to falling in patients with PD.

Efficacy of Herbal Medicine on Sleep Disorders in Parkinson’s Disease: A Review of Randomized Controlled Trials

Objectives: This study reviewed randomized controlled trials (RCTs) investigating the efficacy of herbal medicine on sleep disorders associated with Parkinson’s disease and suggests a better research process.Methods: We searched for RCTs for herbal medicine treatments for sleep disorders related to Parkinson’s disease on July 31, 2023 using eight databases (PubMed, Embase, the Cochrane library, China National Knowledge Infrastructure [CNKI], the Research Information Service System [RISS], Science ON, the Oriental Medicine Advanced Searching Integrated System [OASIS], and the Korea Citation Index [KCI]). Cochrane’s risk of bias tool was used to assess the quality of the RCTs.Results: A total of 16 RCTs met all the inclusion criteria, and in most reports, the treatment group showed a significant improvement in sleep disorders compared to the control group. Total effective rate (TER), Pittsburgh Sleep Quality Index (PSQI), Unified Parkinson’s Disease Rating Scale (UPDRS), TCM Symptom Score (TSS), Parkinson’s Disease Sleep Scale (PDSS), etc., were used as evaluation indicators.Conclusion: Herbal medicine is a potential treatment for sleep disorders associated with Parkinson’s disease. However, the selected RCTs were of poor quality, and it is necessary to perform more systematic studies.

Evaluation of Nocturnal Symptoms in Chinese Parkinson's Disease Patients Based on the PDSS-2 Scale: A Multicenter Cross-Sectional Study.

Nocturnal symptoms have a significant effect on the quality of life in Parkinson's disease (PD) patients. This study aimed to investigate the prevalence and associated factors of nocturnal symptoms in Chinese PD patients. This multicenter cross-sectional study included 1,500 patients with primary PD from 18 centers in China was carried out between February 2019 and February 2020. Questionnaires including Parkinson's disease sleep scale 2 (PDSS-2), Parkinson's disease questionnaire 8 (PDQ-8), Beck depression inventory (BDI), and generalized anxiety disorder scale 7 (GAD-7) were used to assess nocturnal symptoms, quality of life, depression, and anxiety. Among 1,500 Chinese PD patients, 576 (38.4%) reported nocturnal symptoms. Of them, 59.2% were older than 65 years. The PDQ-8 total score was higher in patients with nocturnal symptoms (p <  0.01). Moderate and severe depression was reported more often in patients with nocturnal symptoms (p <  0.01), and the occurrence and severity of anxiety were higher as well (p <  0.01). Longer disease duration and higher Hoehn-Yahr (HY) stage were independently associated with nocturnal symptoms (p <  0.01). Education level, depression, disease course, HY stage, and nocturnal symptoms were related to the quality of life in Chinese PD patients (p <  0.01). Our study found that 38.4% of Chinese PD patients have nocturnal symptoms, even in early and mid-stage PD. Nocturnal symptoms were associated with worse quality of life and higher incidences of depression and anxiety. Nocturnal symptoms should be included in the assessment and care plan, especially in patients with longer disease courses and higher HY stages.

Clinical Manifestations of Subjective Sleep Disorders in Chinese Patients with Parkinson’s Disease and Their Relationship with Dopaminergic Drugs

Introduction: Sleep disorders are common in Parkinson’s disease (PD) and significantly impact quality of life. Herein, we surveyed the incidence and severity of sleep disorders in Chinese PD patients and observed their relationship with dopaminergic drugs. Methods: We collected the demographic and disease information of 232 PD patients. The incidence and severity of sleep disorders were surveyed with the Parkinson’s disease sleep scale (PDSS) Chinese version. Data on dopaminergic drug intake were collected and converted to levodopa equivalent doses (LED). Results: The average total score of PDSS in 232 patients was 119.3 ± 19.7. There was a significant difference in PDSS scores between groups classified by the Hoehn-Yahr (H&Y) stage, but not between the groups classified by the type of dopaminergic drugs. Stepwise regression analysis revealed that the LED of dopaminergic drugs taken before bedtime (p < 0.00), LED of dopaminergic drugs taken over a 24-h period (p < 0.00), and scores of the Hamilton Rating Scale for Depression (HAMD) (p = 0.01) were determinants of PDSS. Conclusion: Sleep disorders in PD patients may be multifactorial. High dosage of dopaminergic drugs taken prior to sleep, daily total high dosage of dopaminergic drugs, and depression exert negative effects on subjective sleep. The timing and dosage of dopaminergic drugs taken before bedtime should be considered in PD management.

Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study.

Foslevodopa/foscarbidopa, a soluble formulation of levodopa/carbidopa (LD/CD) prodrugs for the treatment of Parkinson's disease (PD), is administered as a 24-hour/day continuous subcutaneous infusion (CSCI) with a single infusion site. The efficacy and safety of foslevodopa/foscarbidopa versus oral immediate-release LD/CD was previously demonstrated in patients with PD in a 12-week, randomized, double-blind, phase 3 trial (NCT04380142). We report the results of a separate 52-week, open-label, phase 3 registrational trial (NCT03781167) that evaluated the safety/tolerability and efficacy of 24-hour/day foslevodopa/foscarbidopa CSCI in patients with advanced PD. Male and female patients with levodopa-responsive PD and ≥ 2.5hours of "Off" time/day received 24-hour/day foslevodopa/foscarbidopa CSCI at individually optimized therapeutic doses (approximately 700-4250mg of LD per 24hours) for 52weeks. The primary endpoint was safety/tolerability. Secondary endpoints included changes from baseline in normalized "Off" and "On" time, percentage of patients reporting morning akinesia, Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Parkinson's Disease Sleep Scale-2 (PDSS-2), 39-item Parkinson's Disease Questionnaire (PDQ-39), and EuroQol 5-dimension questionnaire (EQ-5D-5L). Of 244 enrolled patients, 107 discontinued, and 137 completed treatment. Infusion site events were the most common adverse events (AEs). AEs were mostly nonserious (25.8% of patients reported serious AEs) and mild/moderate in severity. At week 52, "On" time without troublesome dyskinesia and "Off" time were improved from baseline (mean [standard deviation (SD)] change in normalized "On" time without troublesome dyskinesia, 3.8 [3.3] hours; normalized "Off" time, -3.5 [3.1] hours). The percentage of patients experiencing morning akinesia dropped from 77.7% at baseline to 27.8% at week 52. Sleep quality (PDSS-2) and quality of life (PDQ-39 and EQ-5D-5L) also improved. Foslevodopa/foscarbidopa has the potential to provide a safe and efficacious, individualized, 24-hour/day, nonsurgical alternative for patients with PD. ClinicalTrials.gov identifier NCT03781167.

Cognitive impairment and dementia in young onset Parkinson's disease.

Patients with young-onset Parkinson's disease (YOPD) have a slower progression. Our aim was to analyze the change in cognitive function in YOPD compared to patients with a later onset and controls. Patients with Parkinson's disease (PD) and controls from the COPPADIS cohort were included. Cognitive function was assessed with the Parkinson's Disease Cognitive Rating Scale (PD-CRS) at baseline (V0), 2-year ± 1month (V2y), and 4-year ± 3months follow-up (V4y). Regarding age from symptoms onset, patients were classified as YOPD (< 50years) or non-YOPD (≥ 50). A score in the PD-CRS < 81 was defined as cognitive impairment (CI): ≤ 64 dementia; 65-80 mild cognitive impairment (MCI). One-hundred and twenty-four YOPD (50.7 ± 7.9years; 66.1% males), 234 non-YOPD (67.8 ± 7.8years; 59.3% males) patients, and 205 controls (61 ± 8.3years; 49.5% males) were included. The score on the PD-CRS and its subscore domains was higher at all visits in YOPD compared to non-YOPD patients and to controls (p < 0.0001 in all analysis), but no differences were detected between YOPD patients and controls. Only non-YOPD patients had significant impairment in their cognitive function from V0 to V4y (p < 0.0001). At V4y, the frequency of dementia and MCI was 5% and 10% in YOPD compared to 25.2% and 22.3% in non-YOPD patients (p < 0.0001). A lower score on the Parkinson's Disease Sleep Scale at baseline was a predictor of CI at V4y in YOPD patients (Adjusted R2 = 0.61; OR = 0.965; p = 0.029). Cognitive dysfunction progressed more slowly in YOPD than in non-YOPD patients.

Deep brain stimulation of the subthalamic nucleus improves sleep in Parkinson disease patients: A systematic review and meta-analysis.

Sleep disorders significantly affect the quality of life in Parkinson disease (PD) patients. Deep brain stimulation of the subthalamic nucleus has been reported to improve motor symptoms and decrease medication usage. However, the impact of subthalamic nucleus deep brain stimulation (STN-DBS) on sleep quality in PD patients remains to be definitively determined. This systematic review and meta-analysis, conducted following the preferred reporting items for systematic reviews and meta-analyses guidelines, aimed to clarify the effect of STN-DBS on sleep quality in PD patients. A rigorous literature search identified 6 studies, including 1 randomized controlled trial and 5 self-controlled trials, totaling 154 patients who underwent deep brain stimulation, providing 308 pairs of data for analysis. Parkinson disease sleep scale was the primary measure of interest, while the Movement Disorder Society-sponsored revision of the unified Parkinson disease rating scale was documented in all trials. Study quality was assessed using the Newcastle-Ottawa scale. STN-DBS significantly improved Parkinson disease sleep scale scores (mean difference = 20.41, 95% CI: [13.03, 27.79], I² = 60.8%, P < .001), indicating enhanced sleep quality. Furthermore, a significant reduction in movement disorder society unified Parkinson disease rating scale part III scores postoperatively (mean difference = -12.59, 95% CI: [-14.70, -10.49], I² = 89.9%, P < .001) suggested improved motor function. PD medication usage was also significantly reduced postoperatively (mean difference = -314.71, 95% CI: [-468.13, -161.28], I² = 52.9%, P < .001). A sensitivity analysis confirmed the robustness of the main findings. The sample size was adequate, allowing for conclusive inferences. The present study, which comprises a comprehensive systematic review and meta-analysis, offers compelling evidence that STN-DBS can ameliorate sleep quality, augment motor function, and curtail medication consumption among individuals afflicted with PD.

Levodopa Carbidopa Intestinal Gel in Advanced Parkinson's Disease: DUOGLOBE Final 3-Year Results.

Levodopa-carbidopa intestinal gel (LCIG) improves motor and non-motor symptoms in patients with advanced Parkinson's disease (aPD). To present the final 36-month efficacy and safety results from DUOGLOBE (DUOdopa/Duopa in Patients with Advanced Parkinson's Disease - a GLobal OBservational Study Evaluating Long-Term Effectiveness; NCT02611713). DUOGLOBE was an international, prospective, long-term, real-world, observational study of patients with aPD initiating LCIG in routine clinical care. The primary endpoint was change in patient-reported "Off" time to Month 36. Safety was assessed by monitoring serious adverse events (SAEs). Significant improvements in "Off" time were maintained over 3 years (mean [SD]: -3.3 hours [3.7]; p < 0.001). There were significant improvements to Month 36 in total scores of the Unified Dyskinesia Rating Scale (-5.9 [23.7]; p = 0.044), Non-Motor Symptoms Scale (-14.3 [40.5]; p = 0.002), Parkinson's Disease Sleep Scale-2 (-5.8 [12.9]; p < 0.001), and Epworth Sleepiness Scale (-1.8 [6.0]; p = 0.008). Health-related quality of life and caregiver burden significantly improved through Months 24 and 30, respectively (Month 24, 8-item Parkinson's Disease Questionnaire Summary Index, -6.0 [22.5]; p = 0.006; Month 30 Modified Caregiver Strain Index, -2.3 [7.6]; p = 0.026). Safety was consistent with the well-established LCIG profile (SAEs: 54.9% of patients; discontinuations: 54.4%; discontinuations due to an adverse event: 27.2%). Of 106 study discontinuations, 32 patients (30.2%) continued LCIG outside the study. DUOGLOBE demonstrates real-world, long-term, reductions in motor and non-motor symptoms in patients with aPD treated with LCIG.