Status:
COMPLETED
Multiple N-of-1 Trials of (Intermittent) Hypoxia Therapy in Parkinson's Disease
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson Disease
Effect of Drug
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
In recent years, mitochondrial dysfunction and oxidative stress have been implicated in PD pathophysiology. Intermittent hypoxia therapy (IHT) is an upcoming treatment used by elite athletes as well a...
Detailed Description
Parkinson's disease (PD) currently affects 10 million people worldwide and its prevalence is projected to exponentially rise further in the absence of disease-modifying therapies. A scarcity of sympto...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Informed consent
- Clinical diagnosis of Parkinson's disease by a movement disorder specialized neurologist with Hoehn and Yahr staging 1.5 to 3.
- 15 individuals with self-reported personal experience of positive altitude effect.
- 5 individuals without self-reported personal experience of positive altitude effect.
- Exclusion criteria:
- Individuals with diseases leading to restrictive and obstructive pulmonary diseases, pulmonary diffusion deficits, apnea and cardiac output deficits, such as pulmonary fibrosis, COPD, sleep apnea or excessive alcoholic intake, and congestive heart failure respectively.
- Arterial blood gas abnormalities at screening day (as per normal limits)
- 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 month)
- 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.
Exclusion
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05214287
Start Date
February 22 2022
End Date
July 12 2023
Last Update
July 21 2023
Active Locations (1)
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1
Dpt. of Physiology, Radboud University Medical Center
Nijmegen, Netherlands, 6525EX