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

A Pilot Study of Acute Intermittent Hypercapnia-Based Interventions on Upper Airway and Axial Motor Function in Parkinson's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether one session of breathing air with more carbon dioxide and either low or normal oxygen can improve breathing, voice, cough, and body movement. It is for adults ages 40 to 75 with Parkinsonism, a condition that affects movement.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 40 to 75 years old.
  • You have idiopathic Parkinsonism (no known cause), rated stage 2 to 4 on the Hoehn and Yahr scale.
  • Your health is stable, and a doctor says you can take part.
  • You can walk at least 10 feet, with or without help.
  • You can follow directions.
  • You agree not to donate blood during the study.

Who can't join

  • You have another condition affecting the brain or nerves.
  • You have a severe illness or infection, including breathing, heart, blood vessel, or lung disease, or uncontrolled high blood pressure.
  • You make a harsh, high-pitched sound when breathing in.
  • You are pregnant. If you might be pregnant, you will get a pregnancy test and may continue if it is negative.
  • You have smoked cigarettes or vaped within the past 5 years.
  • You have had head, neck, or lung cancer, except basal cell carcinoma (a type of skin cancer).
  • You are in another research study that could affect this study’s results.
  • You have implanted wires for deep brain stimulation or have had this treatment before, or you faint or feel lightheaded at the sight of blood.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

FL