Exploring the Relationship Between Varying CO2 Levels and... | NCT00660465

Studies
Exploring the Relationship Between Varying CO2 Levels and the Regional BOLD Signal, by Using Breathing Exercises

NCT00660465

Sponsor

Soroka University Medical Center

Status

Unknown status

Last Update Posted

Nov 11, 2014Estimated

Enrollment

6Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Israel

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

Feb 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 15, 2008

First Submission Date that Met QC Criteria

Apr 16, 2008

First Posted Date

Apr 17, 2008Estimated

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

Nov 9, 2014

Last Update Posted Date

Nov 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to explore how arterial PaCO2 effect regional Blood Oxygen Level Dependent (BOLD) signal, and indirectly the brain regional O2 level .

Detailed Description

Among many parameters effecting cerebral blood flow(CBF), partial pressure of CO2 (PaCO2) in arterial blood has a significant effect. A small increase in arterial PaCO2 level will cause a significant increase of CBF , followed by increase of O2 level . The main objective is to explore the effect of arterial PaCO2 level on regional CBF and brain O2 level, by using breathing exercises to modulate arterial PaCO2. The regional Blood Oxygen Level Dependent (BOLD) signal produced by MRI , will indicate the regional O2 level.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Label	Type	Description	Intervention Names
A18

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults over 18 years old .

Exclusion Criteria:

under 18 years old.
Artificial pacemaker
implantable cardioverter-defibrillator (ICD)
Hearing aid, implantable or portable.
artificial heart valve
Surgical clips
Metal fragments in eyes
Electronic stimulators
Implanted pumps
Implantable Neurostimulation Device
metal fragments of any sort
Permanent makeup or tattoo
transfusion pump
pregnant or breast feeding women
False teeth , retainer or dental crown

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

residents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexander Gersten, Ph.D	Contact	+972-52-3906012		alex.gersten@gmail.com

Overall Officials

Name	Affiliation	Role
Ilan Shelef, M.D	Head, Neuroradiolgy Unit ;Department of Diagnostic Imaging ;Soroka Univrsity Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Diagnostic Imaging ;Soroka Univrsity Medical Center		Beersheba		84101	Israel