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Early-morning off periods, causing early-morning akinesia, can lead to significant motor and nonmotor morbidity in levodopa-treated fluctuating Parkinson’s disease (PD) cases. Despite validated bedside scales in clinical practice, such early-morning off periods may remain undetected unless specific wearable technologies, such as the Parkinson’s KinetiGraph™ (PKG) watch, are used. We report five PD cases for whom the PKG detected early-morning off periods that were initially clinically undetected and as such, untreated. These five cases serve as exemplars of this clinical gap in care. Post-PKG assessment, clinicians were alerted and targeted therapies helped abolish the early-morning off periods.

Early morning OFF (EMO) is one of the first motor complications to manifest and frequently signals the onset of additional motor complications in Parkinson’s Disease (PD). Although EOM are frequently observed in patients with PD and many caregivers must help with their motor inability, the treatment is still unsatisfactory. The majority of research that has been conducted on the wearing-off state of patients with PD has focused on daytime symptoms; evening and early morning symptoms have received much less attention.This study aimed to review the clinical perspectives of current therapies for EMO. We reviewed the searching relevant publications from the key words such as morning off. A total of 456 publications were identified and we reviewed 21 clinical trials as well as other relevant clinical studies and reviews. EMO are frequently disregarded or undervalued, which could have resulted in unintentional risks, inadequate management, and an increased burden of care. Oral medication is still the primary medical intervention for EMO. However, new developments in non-oral medications and advanced formulations aim to reduce the delay in experiencing the benefits of oral levodopa due to gastrointestinal problems. The current therapies for EMO could be helpful in selecting a limited practical treatment. Advancements in non-oral medications and oral formulations hold promise for improving efficacy in EMO. •Early morning OFF (EMO) are frequently observed in patients with PD.•This study aimed to review the clinical perspectives of current therapies for EMO.•EMO could result in inadequate management, and an increased burden of care.•EOM may result from a combination of peripheral pharmacokinetic problems.•Developments in non-oral medications and advanced formulations may reduced EMO.

Background: Early morning off (EMO) refers to off-states in the morning in people diagnosed with Parkinson's disease (PwPD). This study determined the clinical manifestations of EMO and the association with nocturnal sleep problems and quality of life (QOL) in Chinese PwPD. Methods: In this multicenter, observational, cross-sectional study, data concerning the clinical manifestations of EMO were collected from PwPD in Shanghai by questionnaire. The stepwise logistic regression was performed to analyze the potential risk factors, as well as whether EMO was an independent risk factor for functional dependency in daily life. The mediation analyses were conducted to evaluate whether nocturnal sleep problems might mediate the association between EMO and the QOL. Results: Among the 454 subjects evaluated, EMO occurred in 39.43% of PwPD across all disease stages. The prevalence of EMO increased as the Hoehn and Yahr stage increased and was observed in 35.60% of patients in stages 1–2.5 and 48.85% of patients in stages 3–5. EMO was associated with non-motor symptoms (NMSs). The predominant NMSs associated with EMO were nocturnal sleep problems (98.90%), mood/cognition impairment (93.90%), decreased attention/memory (91.60%), gastrointestinal symptoms (91.60%), and urinary urgency (90.50%). The QOL of PwPD with EMO was significantly reduced ( P < 0.001). Moreover, nocturnal sleep problems might partially mediate this relationship (indirect effect: β = 13.458, 95% boot CI: 6.436, 22.042). Conclusion: PwPD have EMO throughout all stages of the disease. Patients with EMO have severe motor symptoms and NMSs. EMO decreases the QOL in PwPD and this relationship is partially mediated by nocturnal sleep problems. In light of these findings, it is suggested that recognition and appropriate treatment of EMO and nocturnal sleep problems could improve the management of PwPD.

Background Early morning off (EMO) is a common feature of Parkinson’s disease (PD). This study aimed to characterize its clinical features and develop a convenient and pragmatic self-assessment instrument in a Chinese nationwide population. Methods This study was conducted on 942 PD patients admitted to 55 clinic centers for movement disorders between June 2018 and May 2019 in China. Stepwise logistic regression analyses were performed to determine potential risk factors and the most predictive symptoms of EMO, as well as whether EMO was an independent risk factor of functional dependency in daily life. Based on this, a 7-question scale was derived for EMO screening. Diagnostic accuracy of this scale was assessed from the area under the receiver operative characteristic curve (AUROC) and its 95% confidence intervals (CIs). We further calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the optimal cutoff point. Results EMO occurred in 49.2% of PD patients across all disease stages. We identified 7 symptoms most predictive of EMO, including bradykinesia or rigidity, excessive sweating or salivation, difficulty in turning on or getting out of bed, muscle cramp, fatigue or sleepiness, frozen state or freezing gait, and tremor. The resulting 7-item scale was confirmed to be of good discrimination with a relatively large AUROC of 0.83, a relatively high sensitivity of 75.7%, specificity of 77.5%, PPV of 76.5%, and NPV of 76.7%. Nonideal nighttime sleep, long PD duration, advanced H&Y stages, posture instability gait difficulty-dominant or mixed subtypes, and high levodopa dose were independently associated with increased risk of EMO. EMO patients were at 87% higher (OR = 1.87, 95%CI: 1.07–3.32) risk of experiencing functional dependency in daily living compared with their counterparts. Conclusions We demonstrated that EMO is a common feature for PD patients across all disease stages and put forward an EMO-specific screening card of sufficient accuracy and brevity. Meanwhile we have thrown some light upon potential determinants and negative health effects of EMO. Our findings may exert great impact on improving the awareness, recognition and management of EMO in PD patients.