Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands.
Radboud University Medical Center, Department of Medical BioSciences, Nijmegen, The Netherlands.
BMC Neurol. 2024 Jun 22;24(1):212. doi: 10.1186/s12883-024-03702-3.
Parkinson's disease (PD) is a neurodegenerative disease for which no disease-modifying therapies exist. Preclinical and clinical evidence suggest that repeated exposure to intermittent hypoxia might have short- and long-term benefits in PD. In a previous exploratory phase I trial, we demonstrated that in-clinic intermittent hypoxia exposure is safe and feasible with short-term symptomatic effects on PD symptoms. The current study aims to explore the safety, tolerability, feasibility, and net symptomatic effects of a four-week intermittent hypoxia protocol, administered at home, in individuals with PD.
METHODS/DESIGN: This is a two-armed double-blinded randomized controlled trial involving 40 individuals with mild to moderate PD. Participants will receive 45 min of normobaric intermittent hypoxia (fraction of inspired oxygen 0.16 for 5 min interspersed with 5 min normoxia), 3 times a week for 4 weeks. Co-primary endpoints include nature and total number of adverse events, and a feasibility-tolerability questionnaire. Secondary endpoints include Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II and III scores, gait tests and biomarkers indicative of hypoxic dose and neuroprotective pathway induction.
This trial builds on the previous phase I trial and aims to investigate the safety, tolerability, feasibility, and net symptomatic effects of intermittent hypoxia in individuals with PD. Additionally, the study aims to explore induction of relevant neuroprotective pathways as measured in plasma. The results of this trial could provide further insight into the potential of hypoxia-based therapy as a novel treatment approach for PD.
ClinicalTrials.gov Identifier: NCT05948761 (registered June 20th, 2023).
帕金森病（PD）是一种神经退行性疾病，目前尚无针对该疾病的治疗方法。临床前和临床证据表明，反复间歇性缺氧可能对 PD 有短期和长期的益处。在之前的探索性 I 期试验中，我们证明了在诊所进行间歇性缺氧暴露是安全且可行的，可在短期内对 PD 症状产生症状性影响。本研究旨在探索在家中进行为期四周的间歇性低氧方案的安全性、耐受性、可行性和净症状性效果，适用于 PD 患者。
方法/设计：这是一项为期四周的双臂双盲随机对照试验，共纳入 40 名轻度至中度 PD 患者。参与者将接受 45 分钟的常压间歇性低氧（吸入氧气分数为 0.16，5 分钟间歇性，5 分钟常氧），每周 3 次，共 4 周。主要终点包括不良事件的性质和总数，以及可行性和耐受性问卷。次要终点包括运动障碍协会统一帕金森病评定量表（MDS-UPDRS）第二部分和第三部分评分、步态测试和生物标志物，这些标志物可指示低氧剂量和神经保护途径的诱导。
该试验基于之前的 I 期试验，旨在研究间歇性低氧对 PD 患者的安全性、耐受性、可行性和净症状性效果。此外，该研究旨在探索相关神经保护途径的诱导，这是通过测量血浆中的标志物来评估的。该试验的结果可能为低氧治疗作为 PD 新的治疗方法提供进一步的深入了解。
ClinicalTrials.gov 标识符：NCT05948761（于 2023 年 6 月 20 日注册）。
