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Cross-System Effects of Acute Intermittent Hypercapnia-Based Interventions in PD

Sponsor: University of Florida • ClinicalTrials.gov ID: NCT07674264

Registry updated: 2026-08-21

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Description

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.

Interventions

Acute intermittent hypercapnic hypoxia (AIHH) (Other)
Participants randomized to Group 1 will breathe brief bouts of AIHH, involving 15, 1.5-min exposures to 9-10% O2 and 4-5% CO2, alternated with 1 minute of 21% O2 (room air).
Acute intermittent hypercapnic normoxia (AIHN) (Other)
Participants randomized to Group 2 will breathe brief bouts of AIHN, involving 15, 1.5-min exposures to 21% O2 and 4-5% CO2, alternated with 1 minute of 21% O2 (room air).

Eligibility criteria

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.

Conditions

Parkinson Disease Parkinsonism

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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