Quantitation of Glymphatic Functioning in Sleep and Meditative States

April 21, 2023 updated by: Daniel Claassen, Vanderbilt University Medical Center
This involves development and application of magnetic resonance imaging (MRI) methods for visualizing hemodynamic and metabolic relationships in healthy volunteers with advanced meditation experience.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is evaluating the glymphatic system during awake, sleep, and meditative states.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212-3160
        • Recruiting
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adept Meditators
Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness.
Behavioral: Meditation
meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

July 1, 2026

Study Completion (Anticipated)

July 1, 2027

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFA-AT-21-001

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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