Intermittent hypoxia treatment for Parkinson's disease
A Randomized Phase 1b-2a Trial of the Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease
This study is testing if a new breathing treatment that involves short periods of low oxygen can help people with Parkinson's disease feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 2 sites (Nijmegen and 1 other locations) |
| Trial ID | NCT05948761 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of intermittent hypoxia therapy in individuals with Parkinson's disease. Participants will undergo 45 minutes of normobaric intermittent hypoxia sessions three times a week for four weeks, with the aim of assessing both the feasibility and symptomatic effects of the treatment. The study builds on previous findings from an exploratory phase I trial, which indicated potential benefits of this non-pharmacological intervention. Secondary outcomes will include the evaluation of neuroprotective pathways through serum analysis.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with mild to moderate Parkinson's disease, specifically those in Hoehn and Yahr stages 1 to 3.
Not a fit: Patients with severe pulmonary or cardiac conditions, or those with active deep brain stimulation, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel non-pharmacological approach to alleviate symptoms of Parkinson's disease.
How similar studies have performed: Previous exploratory trials have shown promise for similar approaches, but this specific treatment's efficacy is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nijmegen and 1 other locations
- Dpt. of Physiology, Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
- Radboud University Medical Center — Nijmegen, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Jules M. Janssen Daalen, MD
- Email: jules.m.janssendaalen@radboudumc.nl
- Phone: 0031243616600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.