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

Last updated: July 13, 2023
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Normoxia through hypoxic generator without active elements

Hypoxia through modified hypoxic generator

Clinical Study ID

NCT05948761
114210
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria

  • Informed consent

  • Clinical diagnosis of Parkinson's disease by a movement disorder specialized neurologist.

  • Hoehn and Yahr staging 1 to and including 3 (indicating mild to moderate 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, sleep apnea and cardiac output deficits, such as pulmonary fibrosis, COPD, sleep apnea or excessive alcoholic intake, and congestive heart failure respectively

  • Individuals with coronary artery disease NYHA classes III and IV

  • Arterial blood gas abnormalities at screening procedure

  • Individuals with shortness of breath or other airway or breathing-related inconvenience related to lack of dopaminergic medication

  • Inability for in-clinic measurements in OFF phase

  • Individuals with active deep brain stimulation

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Normoxia through hypoxic generator without active elements
Phase: 1/2
Study Start date:
July 04, 2023
Estimated Completion Date:
June 01, 2024

Study 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.

Connect with a study center

  • Dpt. of Physiology, Radboud University Medical Center

    Nijmegen, 6525EX
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.