Parkinson Disease
Conditions
Brief summary
To explore the safety, feasibility and net symptomatic effects of multiple (3x/week, for 4 weeks) intermittent hypoxia treatment sessions in individuals with PD. Secondary outcomes include exploring induction of relevant neuroprotective pathways as measured in serum.
Detailed description
Intermittent hypoxia therapy is a non-pharmacological intervention used by athletes and individuals with cardiovascular disease, amongst others. The safety and feasibility of (intermittent) hypoxia therapy and its short-term effects on Parkinson's disease (PD) symptoms were assessed in a previous exploratory phase I trial. However, the net effects of multiple hypoxia treatment sessions on PD symptoms are unknown. The results of the previous phase I trial informed the study design of the newly proposed phase 1b-2a safety and efficacy trial. 45 minutes of normobaric intermittent hypoxia (FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia) will be delivered via a hypoxicator (a device that titrates decreased fractional oxygen from room air) through an oxygen mask in the hospital and subsequently at participants' homes. Interventions will be conducted 3 times a week, for 4 weeks in total.
Interventions
OTHERHypoxia through modified hypoxic generator
Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants.
OTHERNormoxia through hypoxic generator without active elements
Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants, without active elements.
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Identical mode of administration and identical machinery used to deliver the intervention, only inside of machine is different (same ventilator, no active element in the placebo machine)
Intervention model description
Hypoxic conditioning Placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Clinical diagnosis of Parkinson's disease by a movement disorder specialized neurologist. * Hoehn and Yahr staging 1 to and including 3 (indicating mild to moderate PD).
Exclusion criteria
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, sleep apnea and cardiac output deficits, such as pulmonary fibrosis, COPD, sleep apnea or excessive alcoholic intake, and congestive heart failure respectively * Individuals with coronary artery disease NYHA classes III and IV * Arterial blood gas abnormalities at screening procedure * Individuals with shortness of breath or other airway or breathing-related inconvenience related to lack of dopaminergic medication * Inability for in-clinic measurements in OFF phase * Individuals with active deep brain stimulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility questionnaire, overall study success | 1 month | Higher indicates better score |
| Number and nature of adverse events | 2 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Purdue pegboard test (PPT) | 1 month | Higher indicates better score |
| Timed up & Go Test (TUGT) | 1 month | Lower indicates better score |
| Exercise tolerance (6-minute walk test, 6MWT) | 1 month | Higher indicates better score |
| Accelerometry data for tremor amplitude | 1 month | Lower indicates better score |
| Accelerometry data for pronation-supination | 1 month | Higher indicates better score |
| Hematocrit | 1 month | Higher indicates better result |
| BDNF | 1 month | Higher indicates better result |
| Platelet-derived growth factor receptor beta (PDGFRβ) | 1 month | Higher indicates better result |
| Clusterin | 1 month | Higher indicates better result |
| GFAP | 1 month | Higher indicates better result |
| UCH-L1 | 1 month | Higher indicates better result |
| Neurofilament light chain (NfL) | 1 month | Higher indicates better result |
| MDS-UPDRS part II and III | 1 month | Lower indicates better score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parkinson's disease Questionnaire-39 (PDQ-39) | 1 month | Lower indicates better score |
Countries
Netherlands
Outcome results
None listed