CompletedPhase 1/2

Multiple N-of-1 Trials of (Intermittent) Hypoxia Therapy in Parkinson's Disease

Netherlands29 participantsStarted 2022-02-22

Plain-language summary

In recent years, mitochondrial dysfunction and oxidative stress have been implicated in PD pathophysiology. Intermittent hypoxia therapy (IHT) is an upcoming treatment used by elite athletes as well as fragile individuals in clinical settings that works by improving exercise tolerance, neuroplasticity and inducing hypoxic preconditioning (HPC). HPC might improve the oxidative stress response in PD on the long-term. In addition, preclinical evidence suggests beneficial short-term effects such as influence on dopamine and noradrenalin release. Anecdotal evidence indeed suggests that visiting high-altitude areas improves PD symptoms and it is hypothesized that this effect results from decreased oxygen pressure at high altitudes. The safety and feasibility of (intermittent) hypoxia therapy on PD symptoms will be assessed in an exploratory phase I randomized-controlled trial.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Informed consent * Clinical diagnosis of Parkinson's disease by a movement disorder specialized neurologist with Hoehn and Yahr staging 1.5 to 3. * 15 individuals with self-reported personal experience of positive altitude effect. * 5 individuals without self-reported personal experience of positive altitude effect. Exclusion criteria: * Individuals with diseases leading to restrictive and obstructive pulmonary diseases, pulmonary diffusion deficits, apnea and cardiac output deficits, such as pulmonary fibrosis, COPD, sleep apnea or excessive alcoholic intake, and congestive heart failure respectively. * Arterial blood gas abnormalities at screening day (as per normal limits) * Individuals with shortness of breath or other airway or breathing-related inconvenience related to lack of dopaminergic medication will be excluded. * Inability to comply to intervention in off-medication condition (for example due to extreme discomfort, distress or severe head tremor due to being OFF, i.e. without dopaminergic medication). * Individuals with unstable dopaminergic medication dose (changes in the last month) * Individuals likely to start dopaminergic treatment in the next month, also judged by their treating neurologist * Individuals with active deep brain stimulation * Individuals unable to provide informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nature and number of adverse events

Timeframe: Until 3 days post-intervention

Self-reported dizziness, discomfort and stress on a ten-point scale

Timeframe: Until 3 days post-intervention

Blood pressure

Timeframe: Baseline and every 5 mins until 30 mins post-intervention

Heartrate

Timeframe: Baseline and every 5 mins until 30 mins post-intervention

Respiratory rate

Timeframe: Baseline and every 5 mins until 30 mins post-intervention

Oxygen saturation

Timeframe: Baseline and every 5 mins until 30 mins post-intervention

Feasibility questionnaire

Timeframe: After 1st, 5th, 10th post-intervention test

Trial details

NCT IDNCT05214287

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-12

View on ClinicalTrials.gov More Parkinson Disease trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Nature and number of adverse events

Timeframe: Until 3 days post-intervention

Self-reported dizziness, discomfort and stress on a ten-point scale

Timeframe: Until 3 days post-intervention

Blood pressure

Timeframe: Baseline and every 5 mins until 30 mins post-intervention

Heartrate

Timeframe: Baseline and every 5 mins until 30 mins post-intervention

Respiratory rate

Timeframe: Baseline and every 5 mins until 30 mins post-intervention

Oxygen saturation

Timeframe: Baseline and every 5 mins until 30 mins post-intervention

Feasibility questionnaire

Timeframe: After 1st, 5th, 10th post-intervention test