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)
- Registry Record Last Updated
- 2026-06-29 (1 month ago)
- Estimated Commitment
- Lower commitment estimated from the protocol. This reflects time and procedures only — confirm details with the study coordinator.
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.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Hoehn and Yahr stage 2 to 4
- Deep brain stimulation: Cannot join after DBS surgery (deep brain stimulation) (criteria text: "has deep brain stimulation electrodes implanted or has a history of deep brain stimulation 9")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people aged 40 to 75.
- This trial does not enroll people who have had (or are scheduled for) DBS surgery.
- This trial requires Hoehn and Yahr stage 2 to 4.
Locations
- University of Florida, Gainesville, Florida, United States
- Norman Fixel Institute for Neurological Diseases, Gainesville, Florida, United States
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07674264. It is the one about "Improve speech cough and breathing". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: The study involves a single session. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
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?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- 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.