Acute intermittent hypercapnia-based interventions for upper airway and axial control in Parkinsonism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional pilot trial explores whether brief exposure to controlled levels of CO2-related breathing challenges can improve breathing-related and axial motor function in Parkinsonism. Participants will be randomized to receive either acute intermittent hypercapnic hypoxia (AIHH) or acute intermittent hypercapnic normoxia (AIHN) in a single session. The study looks for changes in upper airway control, axial motor performance, and related biomarkers to understand who may respond best. Safety monitoring and feasibility of this approach will also be evaluated. The trial is conducted at the University of Florida and the Norman Fixel Institute, with adults aged 40 to 75 years who have idiopathic Parkinsonism and meet eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. adults 40 to 75 years of age (the latter to reduce the likelihood of cardiovascular disease)
2. diagnosis of idiopathic Parkinsonism with Hoehn and Yahr stages 2-4
3. medically stable with physician clearance
4. ability to ambulate at least 10 feet with/without assistance
5. ability to follow directions
6. willing to abstain from blood donation for the duration of the study

Exclusion Criteria:

1. additional neurologic conditions
2. severe illness or infection, including respiratory/cardiovascular/lung disease, or uncontrolled hypertension
3. inspiratory stridor
4. pregnancy due to unknown tAIH effects on a fetus, although females of childbearing age will not be excluded\*
5. cigarette smoking or vaping within 5 years
6. history of head/neck/lung cancer with the exception of basal cell carcinoma
7. is currently participating in another research study that could influence the results from this study
8. has deep brain stimulation electrodes implanted or has a history of deep brain stimulation
9. faints or becomes lightheaded at the sight of blood

   * If a female of childbearing potential indicates there is a chance she could be pregnant, she will be provided a pregnancy test and allowed to continue in the study if negative. This is because the fetal risks associated with intermittent hypoxia are unknown.

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting
• Norman Fixel Institute for Neurological Diseases
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Michela Mir, CCC-SLP — University of Florida
• Study coordinator: Michlela Mir, CCC-SLP, PhD
• Email: michela.mir@ufl.edu
• Phone: 352-273-6095

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.