A Randomized Phase 1b-2a Trial of the Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number and nature of adverse events
研究概览
简要总结
To explore the safety, feasibility and net symptomatic effects of multiple (3x/week, for 4 weeks) intermittent hypoxia treatment sessions in individuals with PD. Secondary outcomes include exploring induction of relevant neuroprotective pathways as measured in serum.
详细描述
Intermittent hypoxia therapy is a non-pharmacological intervention used by athletes and individuals with cardiovascular disease, amongst others. The safety and feasibility of (intermittent) hypoxia therapy and its short-term effects on Parkinson's disease (PD) symptoms were assessed in a previous exploratory phase I trial. However, the net effects of multiple hypoxia treatment sessions on PD symptoms are unknown. The results of the previous phase I trial informed the study design of the newly proposed phase 1b-2a safety and efficacy trial.
45 minutes of normobaric intermittent hypoxia (FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia) will be delivered via a hypoxicator (a device that titrates decreased fractional oxygen from room air) through an oxygen mask in the hospital and subsequently at participants' homes. Interventions will be conducted 3 times a week, for 4 weeks in total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Identical mode of administration and identical machinery used to deliver the intervention, only inside of machine is different (same ventilator, no active element in the placebo machine)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Clinical diagnosis of Parkinson's disease by a movement disorder specialized neurologist.
- •Hoehn and Yahr staging 1 to and including 3 (indicating mild to moderate PD).
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Individuals with diseases leading to restrictive and obstructive pulmonary diseases, sleep apnea and cardiac output deficits, such as pulmonary fibrosis, COPD, sleep apnea or excessive alcoholic intake, and congestive heart failure respectively
- •Individuals with coronary artery disease NYHA classes III and IV
- •Arterial blood gas abnormalities at screening procedure
- •Individuals with shortness of breath or other airway or breathing-related inconvenience related to lack of dopaminergic medication
- •Inability for in-clinic measurements in OFF phase
- •Individuals with active deep brain stimulation
研究组 & 干预措施
Placebo
Hypoxic generator without active elements, pulsewise ventilation assured to ascertain blinding
干预措施: Normoxia through hypoxic generator without active elements (Other)
Active intervention
FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia (intermittent hypoxia)
干预措施: Hypoxia through modified hypoxic generator (Other)
结局指标
主要结局
Number and nature of adverse events
时间窗: 2 months
Feasibility questionnaire, overall study success
时间窗: 1 month
Higher indicates better score
次要结局
- BDNF(1 month)
- Accelerometry data for tremor amplitude(1 month)
- Neurofilament light chain (NfL)(1 month)
- GFAP(1 month)
- Timed up & Go Test (TUGT)(1 month)
- Exercise tolerance (6-minute walk test, 6MWT)(1 month)
- Accelerometry data for pronation-supination(1 month)
- Hematocrit(1 month)
- Platelet-derived growth factor receptor beta (PDGFRβ)(1 month)
- MDS-UPDRS part II and III(1 month)
- Purdue pegboard test (PPT)(1 month)
- Clusterin(1 month)
- UCH-L1(1 month)