A Randomized Phase 1b-2a Trial of the Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Number and nature of adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, 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)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number and nature of adverse events
Time Frame: 2 months
Feasibility questionnaire, overall study success
Time Frame: 1 month
Higher indicates better score
Secondary Outcomes
- BDNF(1 month)
- Accelerometry data for tremor amplitude(1 month)
- Neurofilament light chain (NfL)(1 month)
- GFAP(1 month)
- Timed up & Go Test (TUGT)(1 month)
- Exercise tolerance (6-minute walk test, 6MWT)(1 month)
- Accelerometry data for pronation-supination(1 month)
- Hematocrit(1 month)
- Platelet-derived growth factor receptor beta (PDGFRβ)(1 month)
- MDS-UPDRS part II and III(1 month)
- Purdue pegboard test (PPT)(1 month)
- Clusterin(1 month)
- UCH-L1(1 month)