PDF(Pubmed)
Abstract：
BACKGROUND: 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: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov Identifier: NCT05948761 (registered June 20th, 2023).
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov Identifier: NCT05948761 (registered June 20th, 2023).
摘要：
背景：帕金森病（PD）是一种神经退行性疾病，目前尚无疾病改善疗法。临床前和临床证据表明，反复暴露于间歇性缺氧可能对PD具有短期和长期益处。在之前的探索性第一阶段试验中，我们证明,临床间歇性低氧暴露是安全可行的,对PD症状有短期症状影响.本研究旨在探讨安全性，耐受性,可行性,以及四周间歇性缺氧方案的净症状效应，在家管理，在PD的个人中。
方法：这是一项双臂双盲随机对照试验，涉及40名轻度至中度PD患者。参与者将接受45分钟的常压间歇性缺氧（5分钟的吸入氧气分数为0.16，穿插5分钟的常氧），每周3次，共4周。共同主要终点包括不良事件的性质和总数，和可行性耐受性问卷。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指示缺氧剂量和神经保护通路诱导。
结论：该试验建立在先前的I期试验的基础上，旨在研究安全性，耐受性,可行性,以及间歇性缺氧对PD患者的净症状影响。此外,本研究旨在探索血浆中相关神经保护通路的诱导。该试验的结果可以进一步了解基于缺氧的治疗作为PD的新型治疗方法的潜力。
背景：ClinicalTrials.gov标识符：NCT05948761（6月20日注册，2023年）。
方法：这是一项双臂双盲随机对照试验，涉及40名轻度至中度PD患者。参与者将接受45分钟的常压间歇性缺氧（5分钟的吸入氧气分数为0.16，穿插5分钟的常氧），每周3次，共4周。共同主要终点包括不良事件的性质和总数，和可行性耐受性问卷。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指示缺氧剂量和神经保护通路诱导。
结论：该试验建立在先前的I期试验的基础上，旨在研究安全性，耐受性,可行性,以及间歇性缺氧对PD患者的净症状影响。此外,本研究旨在探索血浆中相关神经保护通路的诱导。该试验的结果可以进一步了解基于缺氧的治疗作为PD的新型治疗方法的潜力。
背景：ClinicalTrials.gov标识符：NCT05948761（6月20日注册，2023年）。
