NCT06581523 Efficacy of a Breathwork Practice (SKY) on Well-Being of Individuals With Parkinson's Disease (iPD) and Care Partners
| NCT ID | NCT06581523 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nova Southeastern University |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-19 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-10-19 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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\'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.
Eligibility Criteria
Inclusion Criteria: Individuals with Parkinson's Disease (iPD) Inclusion Criteria: An individual with a formal diagnosis of iPD that: * are in stages 1, 2, or 3 * are at least 18 years of age * are no older than 75 years of age * can understand, read, write and speak English at a 5th grade level * that have access to zoom sessions online via laptop, ipad or other mobile device * are able to secure reliable transportation for themselves. Care Partner of the individuals with Parkinson's Disease (iPD) Inclusion Criteria: Individuals who: * are a care partner for an individual with Parkinson's Disease but are not paid professional givers of care * are at least 18 years of age or older * are able to secure reliable transportation for themselves and for the Individual with Parkinson's Disease * can understand, read, write and speak English at a 5th grade level * has access to zoom sessions online via laptop, iPad or other mobile device. Exclusion Criteria: Individuals with Parkinson's Disease (iPD): An individual who * has been diagnosed with Parkinson's Disease that is in stages 4 or 5 of the disease * is younger that age 18 or older than age 75 * has bipolar disorder * has seizure disorder * has schizophrenia or schizoaffective disorder * has active substance use * has uncontrolled hypertension * has cognitive impairment that prevents them from memorizing (remembering) the steps to complete the daily breath and meditation practice or completing the survey instruments, or has difficulty following sequential directions of the breathing practice * cannot understand, read, write and speak English at a 5th grade level * does not have access to zoom sessions online via laptop, iPad or other mobile device * can not secure transportation to the site for the training of the breath and meditation practice Care partner of the Individuals with Parkinson's Disease (iPD): Individuals who: * are paid professional givers of care * are under the age of 18 * an emancipated minor * have bipolar disorder * have seizure disorder * have schizophrenia or schizoaffective disorder * have active substance use * have uncontrolled hypertension * are not able to secure reliable transportation for themselves * cannot understand, read, write and speak English at a 5th grade level * does not have access to access to zoom sessions online via laptop, iPad or other mobile device.
Contact & Investigator
Venetia Bennett, BS, MS, PhD
PRINCIPAL INVESTIGATOR
Nova Southeastern University, Kiran Patel College of Osteopathic Medicine
Frequently Asked Questions
Who can join the NCT06581523 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06581523 currently recruiting?
Yes, NCT06581523 is actively recruiting participants. Contact the research team at vb64@nova.edu for enrollment information.
Where is the NCT06581523 trial being conducted?
This trial is being conducted at Coral Springs, United States, Davie, United States, Fort Lauderdale, United States.
Who is sponsoring the NCT06581523 clinical trial?
NCT06581523 is sponsored by Nova Southeastern University. The principal investigator is Venetia Bennett, BS, MS, PhD at Nova Southeastern University, Kiran Patel College of Osteopathic Medicine. The trial plans to enroll 40 participants.
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