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

University of Florida

Status: Enrolling

Conditions: Parkinson Disease; Parkinsonism

Treatments: Other: Acute intermittent hypercapnic normoxia (AIHN); Other: Acute intermittent hypercapnic hypoxia (AIHH)

Study type: Interventional

Funder types: Other

Identifiers

NCT07674264

IRB202600117

Details and patient eligibility

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Group 1: Acute Intermittent Hypercapnic Hypoxia

Experimental group

Description:

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.

Treatment:

Other: Acute intermittent hypercapnic hypoxia (AIHH)

Group 2: Acute Intermittent Hypercapnic Normoxia

Active Comparator group

Description:

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.

Treatment:

Other: Acute intermittent hypercapnic normoxia (AIHN)