NL-OMON54087已完成不适用
An N-of-1 double-blind randomized phase 1 trial of the safety and feasibility of (intermittent) hypoxia therapy in Parkinson*s disease - TALISMAN-1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Able to provide informed consent
- •- Age >18 years
- •- Clinical diagnosis of Parkinson*s disease by a movement disorder specialized
- •neurologist with Hoehn and Yahr staging 1.5 to 3.
- •- (for age-matched controls: all of the above, except for 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, pulmonary diffusion deficits, apnea and cardiac output deficits, such
- •as pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), sleep
- •apnea or excessive alcoholic intake, and congestive heart failure respectively.
- •- Arterial blood gas abnormalities at screening
- •- Individuals with shortness of breath or other airway or breathing-related
- •inconvenience related to lack of dopaminergic medication will be excluded.
- •- Inability to comply to intervention in off-medication condition (for example
- •due to extreme discomfort, distress or severe head tremor due to being OFF,
- •i.e. without dopaminergic medication).
- •- Individuals with unstable dopaminergic medication dose (changes in the last
- •- Individuals likely to start dopaminergic treatment in the next month, also
- •judged by their treating neurologist
- •- Individuals with active deep brain stimulation
- •- Individuals unable to provide informed consent.
研究者
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