32 Participants NeededMy employer runs this trial

Hypercapnia-Based Interventions for Parkinson's Disease

Recruiting at 1 trial location
MM
AB
Overseen ByAlysha Bogard, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new breathing treatments to help people with Parkinson's disease improve speech, breathing, and muscle control. Participants will engage in brief sessions of breathing higher carbon dioxide levels with either low or normal oxygen, known as Acute Intermittent Hypercapnic Hypoxia (AIHH) and Acute Intermittent Hypercapnic Normoxia (AIHN), respectively. The trial also seeks blood markers to identify who might benefit the most. It suits individuals with Parkinson's disease who can walk at least 10 feet and follow instructions. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for Parkinson's patients.

What prior data suggests that these interventions are safe for Parkinson's patients?

A previous study observed no harmful effects when people with Parkinson's disease experienced intermittent hypoxia, which involves breathing low oxygen levels for short periods. Another study found that this approach, known as acute intermittent hypoxia (AIH), was well-tolerated and did not cause treatment-related side effects.

Research also suggests that adding mild hypercapnia, an increase in carbon dioxide levels, can enhance some benefits of AIH. While these findings are promising, no randomized controlled trials have specifically examined how people with Parkinson’s disease respond to these combined exposures.

Overall, current evidence indicates that the treatments being tested—acute intermittent hypercapnic hypoxia (AIHH) and acute intermittent hypercapnic normoxia (AIHN)—are generally safe and well-tolerated. However, these studies remain in the early stages, and further research is needed to confirm these results.12345

Why are researchers excited about this trial?

Researchers are excited about hypercapnia-based interventions for Parkinson's Disease because they offer a novel approach by utilizing controlled breathing techniques. Unlike standard treatments that primarily target dopamine regulation, these methods involve breathing in increased levels of carbon dioxide (CO2), either with low oxygen (hypoxia) or normal oxygen (normoxia), to potentially improve symptoms. This approach could stimulate the body's natural pathways to enhance neurological function and improve motor skills without relying on medication. By examining upper airway function, axial function, and blood biomarkers before and after treatment, researchers hope to uncover new insights into Parkinson's management.

What evidence suggests that this trial's treatments could be effective for Parkinsonism?

This trial will compare two interventions for Parkinson's disease: Acute Intermittent Hypercapnic Hypoxia (AIHH) and Acute Intermittent Hypercapnic Normoxia (AIHN). Studies have shown that intermittent hypoxia, or occasionally having lower oxygen levels, might improve symptoms in people with Parkinson's disease. It could potentially enhance cognitive abilities and reduce certain disease-related markers. Research also suggests that combining higher carbon dioxide levels with low oxygen, as in AIHH, might better control movement. This combination has shown promising results, such as faster muscle response. Overall, early findings suggest these therapies could offer new ways to manage Parkinson's symptoms.12467

Who Is on the Research Team?

AB

Alysha Bogard, PhD

Principal Investigator

University of Florida

MM

Michela Mir, CCC-SLP

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Parkinson's disease or rapid-onset dystonia-parkinsonism who have issues with breathing, speech, or coughing. Specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

Medically stable with physician clearance
I can walk at least 10 feet, with or without help.
I have idiopathic Parkinson's disease at stage 2, 3, or 4.
See 3 more

Exclusion Criteria

I am not pregnant or have a negative pregnancy test.
Cigarette smoking or vaping within 5 years
Currently participating in another research study that could influence results
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants undergo a single session of acute intermittent hypercapnic hypoxia (AIHH) or hypercapnic normoxia (AIHN) with pre and post testing of upper airway, axial function, and blood-based biomarkers

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in speech loudness, phonation duration, peak expiratory flow rate, and other functional outcomes post-intervention

60 minutes post-intervention

What Are the Treatments Tested in This Trial?

Interventions

  • Acute intermittent hypercapnic hypoxia (AIHH)
  • Acute intermittent hypercapnic normoxia (AIHN)

Trial Overview

Researchers are testing if a single session of two different breathing interventions—AIHH (breathing air with extra carbon dioxide and less oxygen) or AIHN (extra carbon dioxide but normal oxygen)—can help improve airway control and movement in people with Parkinsonism.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group 1: Acute Intermittent Hypercapnic HypoxiaExperimental Treatment1 Intervention
Group II: Group 2: Acute Intermittent Hypercapnic NormoxiaActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Citations

Randomized controlled trial of intermittent hypoxia in ... - PMC

Preclinical and clinical evidence suggest that repeated exposure to intermittent hypoxia might have short- and long-term benefits in PD.

Acute and cumulative effects of hypoxia exposure in people ...

No harmful effects observed during hypoxia exposure in people with Parkinson's disease. •. No randomized controlled trials have investigated hypoxia responses ...

Safety and Effectiveness of Intermittent Hypoxia Treatment ...

The safety and feasibility of (intermittent) hypoxia therapy and its short-term effects on Parkinson's disease (PD) symptoms were assessed in a ...

Acute and cumulative effects of hypoxia exposure in ...

No harmful effects observed during hypoxia exposure in people with Parkinson's disease. •. No randomized controlled trials have investigated hypoxia responses ...

Cross-System Effects of Acute Intermittent Hypercapnia-Based ...

Parkinsonism impairs upper airway and axial motor control, leading to disordered breathing, reduced speech volume, and ineffective cough.

Hypoxia Pathways for Early Recovery After Spinal Cord Injury

Exciting outcomes in >12 SCI trials completed to date demonstrate that AIH improves human respiratory and limb function. Unfortunately, ~40% of individuals ...

Hypoxic conditioning in Parkinson's disease: randomized ...

Intermittent hypoxia at FIO2 0.163 modestly improved most participant-rated symptoms for several hours compared to placebo, but not assessor- ...