Cross-System Effects of Acute Intermittent Hypercapnia-Based Interventions in PD
Recruiting · NCT07674264 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Florida
View the official record on ClinicalTrials.gov →Interventions studied
Acute intermittent hypercapnic hypoxia (AIHH)Acute intermittent hypercapnic normoxia (AIHN)
What this trial is about
Parkinsonism impairs upper airway and axial motor control, leading to disordered breathing, reduced speech volume, and ineffective cough. Symptoms are poorly addressed by current therapies. This randomized pilot trial tests whether a single session of acute intermittent hypercapnic hypoxia (AIHH) or hypercapnic normoxia (AIHN) improves upper airway and axial motor function in Parkinsonism, and explores biomarker correlates of intervention responsiveness.
Who can take part
Age range
40 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- adults 40 to 75 years of age (the latter to reduce the likelihood of cardiovascular disease)
- diagnosis of idiopathic Parkinsonism with Hoehn and Yahr stages 2-4
- medically stable with physician clearance
- ability to ambulate at least 10 feet with/without assistance
- ability to follow directions
- willing to abstain from blood donation for the duration of the study
Exclusion criteria
- additional neurologic conditions
- severe illness or infection, including respiratory/cardiovascular/lung disease, or uncontrolled hypertension
- inspiratory stridor
- pregnancy due to unknown tAIH effects on a fetus, although females of childbearing age will not be excluded\*
- cigarette smoking or vaping within 5 years
- history of head/neck/lung cancer with the exception of basal cell carcinoma
- is currently participating in another research study that could influence the results from this study
- has deep brain stimulation electrodes implanted or has a history of deep brain stimulation
- 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 is running
2 locations listed across 1 US state.
- University of Florida - Gainesville, Florida, United States
- Norman Fixel Institute for Neurological Diseases - Gainesville, Florida, United States