Multiple N-of-1 Trials of (Intermittent) Hypoxia Therapy in Parkinson's Disease (TALISMAN)
Parkinson Disease, Effect of Drug
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Treatment, Intermittent hypoxia therapy, IHT, Disease-modifying treatment, Symptomatic therapy, Neurodegenerative Diseases, Synucleinopathies, Oxygen Deficiency, Hypoxia, Brain, Movement Disorders
Eligibility Criteria
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.
Sites / Locations
- Dpt. of Physiology, Radboud University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Intermittent with 5x5-minutes, FiO2 0.163
Intermittent with 5x5-minutes, FiO2 0.127 or 0.133
Continuous for 45 minutes, FiO2 0.163
Continuous for 45 minutes, FiO2 0.127 or 0.133
Continuous for 45 minutes, FiO2 0.209
Delivered intermittently, with FiO2 0.163 and room-air, each 5 minutes, for 5 cycles/session
Delivered intermittently, with FiO2 0.127 or 0.133 (depending on SaO2 during screening procedure at FiO2 0.127, see study procedures) and room-air, each 5 minutes, for 5 cycles/session
Delivered via the hypoxicator
FiO2 0.127 or 0.133 (depending on SaO2 during screening procedure at FiO2 0.127, see study procedures)
Delivered via an open three-way valve in the circuitry from hypoxicator to the participant