Cross-System Effects of Acute Intermittent Hypercapnia-Based Interventions in PD
Purpose
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.
Conditions
- Parkinson Disease
- Parkinsonism
Eligibility
- Eligible Ages
- Between 40 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Single blind, randomized parallel study design
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- Masking Description
- Each arm involves hypercapnia, while only one includes mild hypoxia. The addition of slightly elevated CO2 in each arm facilitates participant blinding.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1: Acute Intermittent Hypercapnic Hypoxia |
Each participant randomly allocated to this arm will breathe brief bouts of mild acute intermittent hypercapnic hypoxia as the intervention, with PRE and POST testing of upper airway, axial function, and blood-based biomarkers. |
|
|
Active Comparator Group 2: Acute Intermittent Hypercapnic Normoxia |
Each participant randomly allocated to this arm will breathe brief bouts of mild acute intermittent hypercapnic normoxia as the intervention, with PRE and POST testing of upper airway, axial function, and blood-based biomarkers. |
|
Recruiting Locations
University of Florida
Gainesville, Florida 32610
Gainesville, Florida 32610
Norman Fixel Institute for Neurological Diseases
Gainesville, Florida 80303-2181
Gainesville, Florida 80303-2181
More Details
- Status
- Recruiting
- Sponsor
- University of Florida