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Quantitation of Glymphatic Functioning in Sleep and Meditative States

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ClinicalTrials.gov Identifier: NCT04506892
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Daniel Claassen, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE July 17, 2020
First Posted Date  ICMJE August 10, 2020
Last Update Posted Date April 22, 2022
Actual Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2021)
CSF flow change [ Time Frame: baseline to 24 hours ]
Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
CSF flow change [ Time Frame: baseline to 8 weeks ]
Using MRI to assess the change in CSF flow before and after intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2021)
EEG changes [ Time Frame: baseline to 24 hours ]
Looking at brain wave changes before and after intervention in Alpha, Beta, and Delta waves associated with light to deep sleep. The lowest bandwidth for alpha waves is 8 while the highest is 12. The lowest bandwidth for Beta waves is 13 Hz while the highest is 30 Hz. The lowest bandwidth for Delta waves is .4 Hz and the highest is 4 Hz.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
  • EEG changes [ Time Frame: baseline to 8 weeks ]
    Looking at brain wave changes before and after intervention in Alpha, Beta, and Delta waves associated with light to deep sleep. The lowest bandwidth for alpha waves is 8 while the highest is 12. The lowest bandwidth for Beta waves is 13 Hz while the highest is 30 Hz. The lowest bandwidth for Delta waves is .4 Hz and the highest is 4 Hz.
  • Hospital Anxiety and Depression Scale [ Time Frame: baseline to 8 weeks ]
    Looking at behavioral correlates (i.e. anxiety, depression) associated with before and after intervention. There are 2 parts, Anxiety, where the lowest score would be a 0 and the highest is 21, and the higher a score is, the more anxious behaviors there are. The second part is a depressive behavior scale, which the lowest score is 0, and the highest is 21, and the higher the score, the more depressive behaviors there are.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quantitation of Glymphatic Functioning in Sleep and Meditative States
Official Title  ICMJE Quantitation of Glymphatic Functioning in Sleep and Meditative States
Brief Summary This involves development and application of magnetic resonance imaging (MRI) methods for visualizing hemodynamic and metabolic relationships in healthy volunteers with advanced meditation experience.
Detailed Description This study is evaluating the glymphatic system during awake, sleep, and meditative states.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
no masking is used in this protocol
Primary Purpose: Basic Science
Condition  ICMJE
  • Parkinson Disease
  • Sleep
Intervention  ICMJE Behavioral: Meditation
meditation
Study Arms  ICMJE Experimental: Adept Meditators
Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness.
Intervention: Behavioral: Meditation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2027
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages 14-45
  • "Adept meditator status"

Exclusion Criteria:

  • Any non-MR compatible material implant, or contraindication to MR scanning
  • Claustrophobia or inability to lie still for prolonged periods of time
  • Participants with a recent (less than 2 months) infection, tattoo, or wound
  • No consumption of stimulants or alcohol within 12 hours of the study visit
  • clinical diagnosis of any major neurological or psychological condition
  • Taking benzodiazepines, cholinestorase inhibitors, anti-psychotics, opioids, MAO inhibitors
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Daniel Claassen, MD 6153226103 daniel.claassen@vumc.org
Contact: Maria Garza, MS maria.e.garza@vumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04506892
Other Study ID Numbers  ICMJE RFA-AT-21-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Daniel Claassen, Vanderbilt University Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vanderbilt University Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Claassen, MD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP