SKY Breath and Meditation for Parkinson's (NCT06581523)
Breathwork reduces stress and anxiety
- Trial ID
- NCT06581523
- Official Title
- A Feasibility and Efficacy Study of a Breathwork and Meditation Intervention (SKY Breath) on the Psychophysiological Well-Being of Individuals With Parkinson's Disease (iPD) and Their Care Partners
- Goal
- Breathwork reduces stress and anxiety
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Nova Southeastern University
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson's Disease
- Interventions
- SKY Breath and Meditation
Summary For Families
The goal is to reduce stress, anxiety, and improve overall psychophysiological well-being for people with early to mid-stage Parkinson's and their unpaid care partners. The approach teaches SKY Breath, a structured breathwork and meditation program that uses guided rhythmic breathing and relaxation to shift the autonomic nervous system toward more parasympathetic activity, improve heart rate variability, and lower stress and mood symptoms. It is a non-drug intervention, so it does not pharmacologically interact with levodopa, though the study will look at whether the practice helps coping and daily function alongside usual medications. The study is looking for adults 18 to 75 with Parkinson's stage 1 to 3 who can follow and remember the breathing steps, read and speak English, attend online sessions and an in-person training, and also seeks their unpaid care partners; people with advanced PD, certain psychiatric or seizure disorders, uncontrolled hypertension, or active substance use are excluded.
Locations
- Raw Kickboxing and Fitness, Coral Springs, Florida, United States
- David Posnack Jewish Community Center, Davie, Florida, United States
- Nova Southeastern University, Fort Lauderdale, Florida, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying SKY Breath and Meditation. The goal is to reduce stress, anxiety, and improve overall psychophysiological well-being for people with early to mid-stage Parkinson's and their unpaid care partners. The approach teaches SKY Breath, a structured breathwork and meditation program that uses guided rhythmic breathing and relaxation to shift the autonomic nervous system toward more parasympathetic activity, improve heart rate variability, and lower stress and mood symptoms. It is a non-drug intervention, so it does not pharmacologically interact with levodopa, though the study will look at whether the practice helps coping and daily function alongside usual medications. The study is looking for adults 18 to 75 with Parkinson's stage 1 to 3 who can follow and remember the breathing steps, read and speak English, attend online sessions and an in-person training, and also seeks their unpaid care partners; people with advanced PD, certain psychiatric or seizure disorders, uncontrolled hypertension, or active substance use are excluded.
- Who can participate?
- Participants must be between 18 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 3 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and 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 1 year 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?
- You will attend a 4-day in-person active learning program (2.25 hours each day) and then have weekly in-person sessions (about 75 minutes) plus weekly online sessions (about 45 minutes).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.