No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
40 (estimated)
Sponsor
Nova Southeastern University · Other
Who this trial is looking for
This trial is looking for people with early-stage Parkinson's Disease and their caregivers. Participants will learn a specific breathwork and meditation technique over four days and practice it daily for four weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have a diagnosis of early-stage Parkinson's Disease
I am at least 18 years old
I am under 75 years old
I can understand and communicate in English at a basic level
I can access online sessions through a computer or mobile device
I can arrange reliable transportation for myself
I am a caregiver for someone with Parkinson's Disease
I am not paid for providing care
You may not be able to join if
I am in advanced stages 4 or 5 of Parkinson's Disease
I am under 18 years old
I have bipolar disorder
I have a seizure disorder
I have schizophrenia or schizoaffective disorder
I have substance use issues
I have uncontrolled high blood pressure
I cannot understand or communicate in English at a basic level
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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
*…
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.
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