NCT05948761

Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease

A Randomized Phase 1b-2a Trial of the Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	Hypoxia through modified hypoxic generator	Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants.
OTHER	Normoxia through hypoxic generator without active elements	Commercially available hypoxic generator, modified to allow for convenient remote interventions by non-expert participants, without active elements.

Timeline

• Start date: 2023-07-04
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2023-07-17
• Last updated: 2025-08-11

Locations

2 sites across 1 country: Netherlands