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

Phase 1

Recruiting

• Conditions: Parkinson Disease
• Interventions: Other: Hypoxia through modified hypoxic generator; Other: Normoxia through hypoxic generator without active elements

• Registration Number: NCT05948761
• Lead Sponsor: Radboud University Medical Center

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 Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-20
• Study Start: 2023-07-04
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active intervention	Hypoxia through modified hypoxic generator	FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia (intermittent hypoxia)
Placebo	Normoxia through hypoxic generator without active elements	Hypoxic generator without active elements, pulsewise ventilation assured to ascertain blinding

Primary Outcome Measures

Name	Time	Method
Number and nature of adverse events	2 months
Feasibility questionnaire, overall study success	1 month	Higher indicates better score

Secondary Outcome Measures

Name	Time	Method
Accelerometry data for tremor amplitude	1 month	Lower indicates better score
Neurofilament light chain (NfL)	1 month	Higher indicates better result
BDNF	1 month	Higher indicates better result
GFAP	1 month	Higher indicates better result
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 pronation-supination	1 month	Higher indicates better score
Hematocrit	1 month	Higher indicates better result
Platelet-derived growth factor receptor beta (PDGFRβ)	1 month	Higher indicates better result
MDS-UPDRS part II and III	1 month	Lower indicates better score
Purdue pegboard test (PPT)	1 month	Higher indicates better score
Clusterin	1 month	Higher indicates better result
UCH-L1	1 month	Higher indicates better result

Trial Locations

Locations (2)

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Dpt. of Physiology, Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands