Only 10 spots left

~10 spots leftby Jun 2025

Breathwork Practice for Parkinson's Disease
(SKYforiPD Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byVenetia Bennett, BS, MS, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nova Southeastern University

Disqualifiers: Bipolar, Seizure, Schizophrenia, Substance use, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this feasibility study and clinical trial is to learn if an evidenced-based breathwork and meditation intervention (SKY Breath) will improve the mental and physical well-being of individuals with Parkinson's Disease (iPD) in stages 1, 2, and 3, under the age of 75 and their care partners. The main questions it aims to answer are: * Objective 1: Can the SKY Breath practice be designed and implemented to specifically cater to the unique needs of individuals with Parkinson's Disease and their care partners. * Objective 2: Will the SKY Breath practice decrease stress levels (a contributor to increasing PD symptoms) for individuals with Parkinson\&amp;amp;amp;#39;s Disease (iPD) and their care partners as measured through self-reported surveys to improve overall well-being and quality of life. * Objective 3: Will the SKY Breath practice in part alleviate the emotional stress and physical burden experienced by care partners of PD patients, promoting their resilience and well-being. Participants will be asked to learn the SKY Breath and Meditation practice over the course of 4 days (2.25 hours each morning), practice SKY every day for 4 weeks and keep a log of time spent doing SKY. The participants will complete a series of surveys before learning the practice and then after at weeks 1, 4 and 8. The series of surveys will take about 20 minutes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What data supports the effectiveness of the treatment SKY Breath and Meditation for Parkinson's Disease?

Research shows that mindfulness meditation, which is similar to SKY Breath and Meditation, can help improve emotional stability and reduce depressive symptoms in people with Parkinson's Disease. Additionally, yoga, which shares elements with SKY practices, has been shown to improve motor function and balance in individuals with Parkinson's Disease.¹ ² ³ ⁴ ⁵

Is breathwork practice safe for people with Parkinson's Disease?

Research on yoga and meditation practices, similar to breathwork, shows they are generally safe for people with Parkinson's Disease, with no reported adverse events in studies.¹ ² ³ ⁶ ⁷

How is the SKY Breath and Meditation treatment different from other treatments for Parkinson's disease?

SKY Breath and Meditation is unique because it combines specific breathing techniques and meditation to promote relaxation and emotional stability, which can help manage symptoms like stress and depression in Parkinson's disease. Unlike traditional drug treatments, it focuses on mind-body practices to improve overall well-being and resilience.¹ ³ ⁸ ⁹ ¹⁰

Research Team

Venetia Bennett, BS, MS, PhD

Principal Investigator

Nova Southeastern University, Kiran Patel College of Osteopathic Medicine

Eligibility Criteria

This trial is for individuals with Parkinson's Disease in stages 1, 2, or 3 and under the age of 75, as well as their care partners. Participants must be willing to learn and practice SKY Breath meditation daily for four weeks and complete several surveys.

Inclusion Criteria

I have been diagnosed with early or mid-stage Parkinson's disease, am under 76, and can use Zoom.

I am a volunteer caregiver, over 18, with reliable transport and can use Zoom.

Exclusion Criteria

I am a care partner, over 18, can get to places on my own, and can use Zoom on a device.

I cannot participate due to advanced Parkinson's, severe cognitive issues, or lack of English or online access.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Learning Phase

Participants learn the SKY Breath and Meditation practice over 4 days, 2.25 hours each morning

1 week

4 visits (in-person)

Home Practice and Booster Sessions

Daily home practice with weekly online and in-person guided sessions

8 weeks

8 visits (in-person), 8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

SKY Breath and Meditation (Behavioral Intervention)

Trial OverviewThe study tests if SKY Breathwork and Meditation can improve mental and physical well-being in people with Parkinson's Disease (stages 1-3) and their caregivers. It involves learning the technique over four days then practicing it daily while tracking progress through surveys.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Individual with Parkinson's DiseaseExperimental Treatment1 Intervention

The intervention is the Sudarshan Kriya Yoga or SKY Breath and Meditation Practice. This will be taught over a 10-12 hour period, 2.25 hours for 4 early mornings. The participants will practice 6 days a week (a 35-45 minute practice)for a total of 8 weeks.

Group II: Care Partner of Individual with Parkinson's DiseaseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Dr. George L. Hanbury II

Nova Southeastern University

Chief Executive Officer since 2011

PhD in Higher Education Administration from Nova Southeastern University

Dr. Gary S. Margules

Nova Southeastern University

Chief Medical Officer since 2010

MD from University of Miami

Findings from Research

Complementary and alternative medicine (CAM) therapies, such as Tai Chi, yoga, and acupuncture, show some evidence of benefits for nonmotor symptoms (NMS) in Parkinson's disease, particularly in areas like sleep, cognition, and depression, although the studies often involve small sample sizes and lack standardization.

Exercise therapies, including occupational and physical therapy, have demonstrated potential benefits for NMS like depression and anxiety in Parkinson's patients, but the sustainability of these improvements remains uncertain due to short follow-up durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and Alternative Medicine and Exercise in Nonmotor Symptoms of Parkinson's Disease.Subramanian, I.[2022]

A study involving 66 patients with Parkinson's disease showed that Autogenic Training (AT) combined with Physiotherapy (PT) significantly improved motor performance compared to PT alone, with improvements of 51.78% in the AT group versus 35.24% in the control group after 8 weeks.

The benefits of AT persisted even at the 12-week follow-up, indicating that AT is an effective adjunct therapy for enhancing motor skills in Parkinson's disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of autogenic training in improving motor performances in Parkinson's disease.Ajimsha, MS., Majeed, NA., Chinnavan, E., et al.[2022]