HealthyNCT00660465
Exploring the Relationship Between Varying CO2 Levels and the Regional BOLD Signal, by Using Breathing Exercises
An observational study of Healthy, run by Soroka University Medical Center at 1 site in Israel.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: residents
Who may be able to join
- adults over 18 years old .
Who cannot join
- under 18 years old.
- Artificial pacemaker
- implantable cardioverter-defibrillator (ICD)
- Hearing aid, implantable or portable.
- artificial heart valve
- Surgical clips
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Diagnostic Imaging ;Soroka Univrsity Medical Center
Beersheba, 84101
Ilan Shelef, M.D, +972-8-6403950, shelef@bgu.ac.il
Alexander Gersten, Ph.D
About this study
Official title: Exploring the Relationship Between Varying CO2 Levels and the Regional BOLD Signal, by Using Breathing Exercises .
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 .
Read the 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.
- Conditions
- Healthy
- Keywords
- Regional BOLD signal dependency on arterial PaCO2., Effect of breathing exercises on brain regional O2 level., Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A18 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Ilan Shelef, M.D, Study director, Head, Neuroradiolgy Unit ;Department of Diagnostic Imaging ;Soroka Univrsity Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660465
- Sponsor's protocol ID
- SOR467608CTIL
- Status last verified
- Feb 2008
- First submitted
- 15 Apr 2008
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between Varying CO2 Levels and the Regional BOLD Signal, by Using Breathing Exercises .
- ClinicalTrials.gov ID
- NCT00660465
- Acronym / sponsor ID
- SOR467608CTIL
- Conditions
- Healthy
- Keywords
- Regional BOLD signal dependency on arterial PaCO2., Effect of breathing exercises on brain regional O2 level., Healthy subjects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- May 2008
- First posted
- 17 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A18 | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- residents
Key inclusion criteria (1 listed)
- adults over 18 years old .
Key exclusion criteria (15 listed)
- under 18 years old.
- Artificial pacemaker
- implantable cardioverter-defibrillator (ICD)
- Hearing aid, implantable or portable.
- artificial heart valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Shelef, M.D study director
Head, Neuroradiolgy Unit ;Department of Diagnostic Imaging ;Soroka Univrsity Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Gersten, Ph.D (+972-52-3906012, alex.gersten@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014; AzTrials last refreshed its copy on 2 Nov 2026.