Randomized controlled trial of intermittent hypoxia in Parkinson's disease: study rationale and protocol
- PMID: 38909201
- PMCID: PMC11193237
- DOI: 10.1186/s12883-024-03702-3
Randomized controlled trial of intermittent hypoxia 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 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.
Discussion: 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.
Trial registration: ClinicalTrials.gov Identifier: NCT05948761 (registered June 20th, 2023).
Keywords: Disease modification; Disease-modifying tria; Hypoxia; Mitochondrial dysfunction; Oxidative stress; Parkinson's disease; hypoxic conditioning.
© 2024. The Author(s).
Conflict of interest statement
Bastiaan R. Bloem has received honoraria from serving on the scientific advisory board for Abbvie, Biogen, UCB, and Walk with Path; has received fees for speaking at conferences from AbbVie, Zambon, Roche, GE Healthcare, and Bial; and has received research support from The Netherlands Organisation for Scientific Research, the Michael J. Fox Foundation, UCB, Abbvie, the Stichting Parkinson Fonds, the Hersenstichting Nederland, the Parkinson Foundation, Verily Life Sciences, Horizon 2020, the Topsector Life Sciences and Health, and the Parkinson Vereniging. The other authors have nothing to disclose.
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