Recruiting

SKY

Sponsor:

Nova Southeastern University

Code:

NCT06581523

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

SKY Breath and Meditation

Study Details

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.

Conditions

Parkinson's Disease

Study ID

NCT06581523

Start date

Oct 19, 2024

Status verified date

Feb, 2026

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Individual with Parkinson's Disease

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.

experimental: Care Partner of Individual with Parkinson's Disease

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.

Interventions

SKY Breath and Meditation

SKY Breath and Meditation is a unique breath-based technique that uses cyclical, rhythmic patterns of breath to bring the mind and body effortlessly into meditation. It has been empirically validated and holds distinct advantages over other forms of meditation.

Primary outcome measure

  • Stress management for Individuals with Parkinson's Disease [ Time Frame: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention ]
  • Stress management for Care Partners of Individuals with Parkinson's Disease [ Time Frame: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention ]
  • Psycho-social well-being management for Individuals with Parkinson's Disease [ Time Frame: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention ]
  • Psycho-social well-being management for Care Partners of Individuals with Parkinson's Disease [ Time Frame: Pre-intervention, and 2 weeks, 4 weeks, 8 weeks post intervention ]
  • Parkinson's Disease Symptom management/Relief [ Time Frame: Pre-intervention, and at 2 weeks, 4 weeks and 8 weeks post intervention ]

Central Contacts and Locations

Central contacts

Venetia Bennett, BS, MS, PhD

954-263-6535vb64@nova.edu

Sharon C Siegel, DDS, MS, MBA

410-935-8857scsiegel@nova.edu

Locations

Raw Kickboxing and Fitness

Recruiting

Coral Springs, Florida, United States, 33071

Contacts

Mark Barker, BA

954-575-6000

Allie Barker

954-309-7814

Nova Southeastern University

Recruiting

Fort Lauderdale, Florida, United States, 33328

Contacts

Rania Massad, BA, DPT

305-505-5465rania@nova.edu

Venetia Bennett, BA, MS, PhD

954-263-6535vb64@nova.edu

Principal Investigator:

Venetia Bennett, BA, MS, PhD

More Information

Sponsor

Nova Southeastern University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Parkinson's Disease
  • Sudarshan Kriya Yoga
  • SKY Breath and Meditation
  • Care Partner of Individuals with Parkinson's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nova Southeastern University on 2026-02-27.