Quantitation of Glymphatic Functioning in Sleep and Medit... | NCT04506892

Studies
Quantitation of Glymphatic Functioning in Sleep and Meditative States

NCT04506892

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Aug 6, 2025Actual

Enrollment

75Actual

Phase

Not Applicable

Conditions

Parkinson Disease
Sleep

Interventions

Meditation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Dec 1, 2024Actual

Completion Date

Dec 1, 2024Actual

First Submitted Date

Jul 17, 2020

First Submission Date that Met QC Criteria

Aug 6, 2020

First Posted Date

Aug 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2025

Last Update Posted Date

Aug 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daniel Claassen, Associate Professor, Vanderbilt University Medical CenterPrincipal Investigator

Lead Sponsor

Vanderbilt University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adept Meditators	Experimental	Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness.	Behavioral: Meditation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meditation	Behavioral	meditation	Adept Meditators

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CSF flow change	Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states	baseline to 24 hours

Secondary Outcomes

Measure	Description	Time Frame
EEG changes	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Claassen, MD	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37212-3160	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019122	Meditation

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies

Browse Leaves

Not provided

Browse Branches

Not provided