NCT07674264 Cross-System Effects of Acute Intermittent Hypercapnia-Based Interventions in PD
| NCT ID | NCT07674264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-08-12 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2026-08-12 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Michela Mir, CCC-SLP
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT07674264 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07674264 currently recruiting?
Yes, NCT07674264 is actively recruiting participants. Contact the research team at michela.mir@ufl.edu for enrollment information.
Where is the NCT07674264 trial being conducted?
This trial is being conducted at Gainesville, United States, Gainesville, United States.
Who is sponsoring the NCT07674264 clinical trial?
NCT07674264 is sponsored by University of Florida. The principal investigator is Michela Mir, CCC-SLP at University of Florida. The trial plans to enroll 32 participants.
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