NL-OMON54087
Completed
Not Applicable
An N-of-1 double-blind randomized phase 1 trial of the safety and feasibility of (intermittent) hypoxia therapy in Parkinson*s disease - TALISMAN-1
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Able to provide informed consent
- •\- Age \>18 years
- •\- Clinical diagnosis of Parkinson\*s disease by a movement disorder specialized
- •neurologist with Hoehn and Yahr staging 1\.5 to 3\.
- •\- (for age\-matched controls: all of the above, except for 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, pulmonary diffusion deficits, apnea and cardiac output deficits, such
- •as pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), sleep
- •apnea or excessive alcoholic intake, and congestive heart failure respectively.
- •\- Arterial blood gas abnormalities at screening
- •\- 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
Outcomes
Primary Outcomes
Not specified
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