Acute intermittent hypercapnic hyp… for Parkinson's (NCT07674264)
Improve speech cough and breathing
- Trial ID
- NCT07674264
- Official Title
- A Pilot Study of Acute Intermittent Hypercapnia-Based Interventions on Upper Airway and Axial Motor Function in Parkinson's Disease
- Goal
- Improve speech cough and breathing
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Florida
- Study Type
- INTERVENTIONAL
- Enrollment
- 32 participants
- Conditions
- Parkinson Disease, Parkinsonism
- Interventions
- Acute intermittent hypercapnic hypoxia (AIHH), Acute intermittent hypercapnic normoxia (AIHN)
Summary For Families
It is testing whether a single session of brief, repeated breathing exposures can improve upper airway and trunk problems in Parkinsonism, such as disordered breathing, quieter speech, and weak cough that are not well helped by current treatments. The study compares two breathing approaches: one with higher carbon dioxide and lower oxygen, and one with higher carbon dioxide but normal oxygen, to see if either boosts upper airway and axial motor function and to look for biological signs that predict who benefits. Adults 40 to 75 with idiopathic Parkinsonism at moderate stages (Hoehn and Yahr 2 to 4), who are medically stable, can walk at least 10 feet, and can follow directions may be eligible; people with serious lung or heart disease, recent smoking, deep brain stimulation, or pregnancy risk are excluded.
Locations
- University of Florida, Gainesville, Florida, United States
- Norman Fixel Institute for Neurological Diseases, Gainesville, Florida, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Acute intermittent hypercapnic hypoxia (AIHH). It is testing whether a single session of brief, repeated breathing exposures can improve upper airway and trunk problems in Parkinsonism, such as disordered breathing, quieter speech, and weak cough that are not well helped by current treatments. The study compares two breathing approaches: one with higher carbon dioxide and lower oxygen, and one with higher carbon dioxide but normal oxygen, to see if either boosts upper airway and axial motor function and to look for biological signs that predict who benefits. Adults 40 to 75 with idiopathic Parkinsonism at moderate stages (Hoehn and Yahr 2 to 4), who are medically stable, can walk at least 10 feet, and can follow directions may be eligible; people with serious lung or heart disease, recent smoking, deep brain stimulation, or pregnancy risk are excluded.
- Who can participate?
- Participants must be between 40 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 6 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- The study involves a single session.