Multiple N-of-1 trials to investigate hypoxia therapy in Parkinson's disease: study rationale and protocol.

ABSTRACT:

Background

Parkinson's disease (PD) is a neurodegenerative disease, for which no disease-modifying therapies exist. Preclinical and clinical evidence suggest that hypoxia-based therapy might have short- and long-term benefits in PD. We present the contours of the first study to assess the safety, feasibility and physiological and symptomatic impact of hypoxia-based therapy in individuals with PD.

Methods/design

In 20 individuals with PD, we will investigate the safety, tolerability and short-term symptomatic efficacy of continuous and intermittent hypoxia using individual, double-blind, randomized placebo-controlled N-of-1 trials. This design allows for dose finding and for including more individualized outcomes, as each individual serves as its own control. A wide range of

SUBMITTER: Janssen Daalen JM 

PROVIDER: S-EPMC9281145 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature