Evidence map›Paper›PMID 38909201›Full record

ArticleBMC neurology2024

Randomized controlled trial of intermittent hypoxia in Parkinson's disease: study rationale and protocol.

Jules M Janssen Daalen, Marjan J Meinders, Soania Mathur, Hieronymus W H van Hees, Philip N Ainslie, Dick H J Thijssen, Bastiaan R Bloem

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05948761 (A Randomized Phase 1b-2a Trial of the Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05948761 phase1 / phase2completednot on this map

A Randomized Phase 1b-2a Trial of the Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease

TypeinterventionalSponsorRadboud University Medical CenterRan2023 to 2024Enrolled40ConditionsParkinson DiseaseArmsHypoxia through modified hypoxic generator, Normoxia through hypoxic generator without active elements
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Hypoxia in multiple sclerosis.Redox biology · 2025
    Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jules M Janssen DaalenRadboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands. Jules.M.JanssenDaalen@radboudumc.nl.
Marjan J MeindersRadboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands.
Soania MathurUnshakeableMD, Oshawa, ON, Canada.
Hieronymus W H van HeesRadboud University Medical Center, Department of Pulmonary Diseases, Nijmegen, The Netherlands.
Philip N AinslieUniversity of British Columbia, Center for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, Kelowna, Canada.
Dick H J ThijssenRadboud University Medical Center, Department of Medical BioSciences, Nijmegen, The Netherlands.
Bastiaan R BloemRadboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands. Bas.Bloem@radboudumc.nl.

Funding

Michael J. Fox Foundation for Parkinson's Research MJFF-019201
6 · The paper itself

Abstract

backgroundParkinson'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/

designThis 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 registrationClinicalTrials.gov Identifier: NCT05948761 (registered June 20th, 2023).

Indexed as

HypoxiaParkinson DiseaseAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicDisease modificationDisease-modifying triaHypoxiahypoxic conditioningMitochondrial dysfunctionOxidative stressParkinson's disease

Identifiers

PMID38909201
PMCPMC11193237

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.