Cerebrovascular RegulationNCT06142045
Brain Blood Flow Responses at Rest and During Exercise
An observational study of Cerebrovascular Regulation, run by University of British Columbia.
Trial summary
Tight regulation of brain blood flow is integral for delivery of oxygen and energy for survival. During childhood, the brain has a twofold higher metabolic requirement, thus requires greater blood flow to match this. Read more about this study
- Who is it for?
- Ages 7 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Regulation
- What is being tested?
- RespirACT RA-MR System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Jan 2025
- 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 7 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will be healthy children, adolescents and adults between the ages of 7-10 years, 12-16 years or 19-35 years of age. Participants will be recruited from the general population from online advertisements and media, targeting children, adolescents and adults residing in the Okanagan, British Columbia.
Who may be able to join
- Are aged between 7-10 years, 12-16 years or 19-35 years
- Male or Female
- Have a normal blood pressure (<160/110 mmHg) and are not taking any anti-hypertensive medications.
- No prior or current history of cardiorespiratory of cerebrovascular diseases.
- Can communicate in English
Who cannot join
- Inability to perform handgrip exercise
- Are currently taking any medications known to influence vascular function, heart rate or blood pressure
- Have epilepsy
- Are a current smoker
- Have known cardiometabolic abnormalities
- Have congenital cardiac abnormalities (e.g., tetralogy of Fallot)
Show all 16Show fewer
- Unstable angina (frequent chest pain)
- Atrial Fibrillation
- Myocardial infarction (heart attack) within the previous 3 months
- Transient ischemic attack (TIA) within the previous 6 months
- Heart failure ≥ class 2
- Have a known respiratory disease (e.g., asthma)
- Have a known metabolic disease (e.g., Type 1 diabetes)
- Are unable to exercise
- Are pregnant
- Less than 6 months post childbirth or stopped breastfeeding within the last month
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cerebrovascular Responses to Isometric Exercise, and Hypercapnia in Children, Adolescents and Adults
Tight regulation of brain blood flow is integral for delivery of oxygen and energy for survival. During childhood, the brain has a twofold higher metabolic requirement, thus requires greater blood flow to match this. Despite this knowledge, brain blood flow responses and the mechanisms of regulation during maturation are largely unknown. Thus, we are trying to understand what happens to blood vessel function and the mechanisms of regulation at rest and during handgrip exercise. This will give us valuable information on brain blood vessel responses, which will help future interventions aimed at improving blood vessel function in youth, for future disease prevention. Utilizing the pubertal transition will provide insights into the influence of sex hormones on brain blood flow regulation.
The goal of this cross-sectional observational study is to examine the influence of age and maturation on cerebral blood flow regulation, achieved through exploring the responses to increases in carbon dioxide concentrations, and static handgrip exercise in children (7-10 years), adolescents (12-16 years) and young adults (19-35 years).
Read more
The main questions the study aims to answer are:
- Investigate the brain blood flow responses to increases in carbon dioxide concentrations in children, adolescents and adults.
- Investigate brain blood flow responses to handgrip exercise with and without increases in carbon dioxide concentrations in children, adolescents and adults.
During all protocols, participants will have their end-tidal gas concentrations measured and/or altered using prospective end-tidal gas targeting using a computer controlled gas blender system in which we have obtained Health Canada approval for.
Read the detailed description
The goal of this cross-sectional experimental study to determine the influence age, sex and pubertal status on cerebrovascular responses at rest and during isometric exercise.
The main objective is to investigate the regulatory mechanisms of cerebral blood flow during hypercapnia and isometric exercise, and determine whether any mechanistic differences in regulation are present with advancing age and maturation.
The following questions will be addressed in 20 healthy children (7-10 years), 20 healthy adolescents (12-16 years) and 20 young healthy adults (19-35 years), to compare the influence of age, sex and maturation on these responses, as follows:
- Investigate the brain blood flow responses to isometric exercise with and without hypercapnia (+9 mmHg carbon dioxide) in children, adolescents and adults.
- Investigate the brain blood flow responses to hypercapnia (+9 mmHg carbon dioxide) in children, adolescents and adults using a ramp incremental 4 minute protocol compared with a 30 second protocol, to identify which method is the most tolerable in children and adolescents.
- Determine whether sex, and the sex-dependent influences of age and maturation influence any of the brain blood flow responses to hypercapnia or isometric handgrip exercise.
To control and manipulate breathing gases during the study protocols, the partial pressures of end-tidal carbon dioxide and oxygen will be sampled at the mouth using the Investigational Testing Authorization approved computer controlled gas blender system. To target specific end-tidal carbon dioxide and oxygen levels during the clamped breathing and hypercapnic trials respectively, prospective end-tidal gas targeting will be utilized. The system allows for breath-by-breath regulation of end-tidal gases, independently of ventilation. End-tidal concentrations are prospectively targeted by controlling the inspired concentration of carbon dioxide and oxygen according to the previous expired breath, allowing this to be precisely controlled throughout the duration of the protocol. Gas analysis, and spirometry measures of tidal volume and breathing frequency will be recorded using the computer controlled system. Prospective end-tidal gas targeting is safe, with all inspired gases containing oxygen, with rigorous control procedures and fail-safe mechanisms which do not allow inhaled gases to fall outside of safe thresholds.
- Conditions
- Cerebrovascular Regulation
- Being tested
- RespirACT RA-MR System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespirACT RA-MR SystemDevice
RespirAct RA-MR™ is a computer-controlled gas blender to implement precise control of blood gases for a consistent and repeatable stimulus.
| Study group | Role | What they receive |
|---|---|---|
| Children (7-10 years) | All groups of the experiment will be exposed to the same intervention. The intervention the participants are exposed to is the use of the computer controlled gas blender system for manipulation of end-tidal and arterial blood gases. This will be used for the following protocols, to either clamp end-tidal concentrations at resting levels or administer a hypercapnia challenge. The protocol includes assessment of cerebral blood flow responses (measured using ultrasound) to carbon dioxide; including a hypercapnia ramp protocol followed by a transient protocol. Following at least 30 minute wash out, participants will then perform isometric exercise at 30% of their maximal voluntary contraction for 2 minutes. Participants will perform the isometric handgrip exercise under 2 different conditions (hypercapnia (+9 mmHg) and clamped breathing; to maintain baseline end-tidal carbon dioxide and oxygen concentrations) with a 20-minute recovery period between each bout. Receives: Device: RespirACT RA-MR System | |
| Adolescents (12-16 years) | All groups of the experiment will be exposed to the same intervention. The intervention the participants are exposed to is the use of the computer controlled gas blender system for manipulation of end-tidal and arterial blood gases. This will be used for the following protocols, to either clamp end-tidal at resting levels or administer a hypercapnia challenge. The protocol includes assessment of cerebral blood flow responses (measured using ultrasound) to carbon dioxide; including a hypercapnia ramp protocol followed by a transient protocol. Following at least 30 minute wash out, participants will then perform isometric exercise at 30% of their maximal voluntary contraction for 2 minutes. Participants will perform the isometric handgrip exercise under 2 different conditions (hypercapnia (+9 mmHg) and clamped breathing; to maintain baseline end-tidal carbon dioxide and oxygen concentrations) with a 20-minute recovery period between each bout. Receives: Device: RespirACT RA-MR System | |
| Adults (18-35 years) | All groups of the experiment will be exposed to the same intervention. The intervention the participants are exposed to is the use of the computer controlled gas blender system for manipulation of end-tidal and arterial blood gases. This will be used for the following protocols, to either clamp end-tidal at resting levels or administer a hypercapnia challenge. The protocol includes assessment of cerebral blood flow responses (measured using ultrasound) to carbon dioxide; including a hypercapnia ramp protocol followed by a transient protocol. Following at least 30 minute wash out, participants will then perform isometric exercise at 30% of their maximal voluntary contraction for 2 minutes. Participants will perform the isometric handgrip exercise under 2 different conditions (hypercapnia (+9 mmHg) and clamped breathing; to maintain baseline end-tidal carbon dioxide and oxygen concentrations) with a 20-minute recovery period between each bout. Receives: Device: RespirACT RA-MR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
Ultrasound assessment of the internal carotid artery blood flow
Measured: Experimental visit (1 day)
Secondary outcomes (7)
Cerebral blood velocity
Ultrasound assessment of the middle cerebral artery velocity
Measured: Experimental visit (1 day)
Beat-by-beat blood pressure
Continuous assessment of mean arterial pressure responses
Measured: Experimental visit (1 day)
Saliva hormone concentrations
Saliva specimen samples for the assessment of estrogen, progesterone, dehydroepiandrosterone and testosterone for the characterization of maturation status
Measured: Experimental visit (1 day)
Physical activity questionnaire
Self report assessments of physical activity levels will be assessed
Measured: Experimental visit (1 day)
Anthropometrics: weight
Body mass (kg) will be measured with electronic scales
Measured: Experimental visit (1 day)
Gas analysis
The partial pressures of end-tidal carbon dioxide and oxygen will be sampled at the mouth from a fitted respiratory face mask.
Measured: Experimental visit (1 day)
Anthropometrics: height
Stature standing and sitting height will be measured (cm).
Measured: Experimental visit (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 May 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular RegulationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ai McManus, University of British Columbia
- Investigators
- Jared Baylis, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142045
- Sponsor's protocol ID
- H23-02316
- Status last verified
- Mar 2024
- First submitted
- 13 Nov 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized data from this study will be made available for sharing with other investigators, after publication of the study's key papers. Data will be shared through the Federated Research Data Repository (FRDR) (https://www.frdr-dfdr.ca/repo/). This is a secure data repository, which is searchable on the www, it is managed by Library Services. A digital object identifier (DOI) will be generated for datasets as they are deposited to the repository. Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
Publications
Ito S, Mardimae A, Han J, Duffin J, Wells G, Fedorko L, Minkovich L, Katznelson R, Meineri M, Arenovich T, Kessler C, Fisher JA. Non-invasive prospective targeting of arterial P(CO2) in subjects at rest. J Physiol. 2008 Aug 1;586(15):3675-82. doi: 10.1113/jphysiol.2008.154716. Epub 2008 Jun 19.
PubMed 18565992Fisher JA. The CO2 stimulus for cerebrovascular reactivity: Fixing inspired concentrations vs. targeting end-tidal partial pressures. J Cereb Blood Flow Metab. 2016 Jun;36(6):1004-11. doi: 10.1177/0271678X16639326. Epub 2016 Mar 21.
PubMed 27000209
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Responses to Isometric Exercise, and Hypercapnia in Children, Adolescents and Adults
- ClinicalTrials.gov ID
- NCT06142045
- Acronym / sponsor ID
- H23-02316
- Conditions
- Cerebrovascular Regulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 21 Nov 2023 (actual)
- 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.
Tight regulation of brain blood flow is integral for delivery of oxygen and energy for survival. During childhood, the brain has a twofold higher metabolic requirement, thus requires greater blood flow to match this. Despite this knowledge, brain blood flow responses and the mechanisms of regulation during maturation are largely unknown. Thus, we are trying to understand what happens to blood vessel function and the mechanisms of regulation at rest and during handgrip exercise. This will give us valuable information on brain blood vessel responses, which will help future interventions aimed at improving blood vessel function in youth, for future disease prevention. Utilizing the pubertal transition will provide insights into the influence of sex hormones on brain blood flow regulation.
The goal of this cross-sectional observational study is to examine the influence of age and maturation on cerebral blood flow regulation, achieved through exploring the responses to increases in carbon dioxide concentrations, and static handgrip exercise in children (7-10 years), adolescents (12-16 years) and young adults (19-35 years).
The main questions the study aims to answer are:
- Investigate the brain blood flow responses to increases in carbon dioxide concentrations in children, adolescents and adults.
- Investigate brain blood flow responses to handgrip exercise with and without increases in carbon dioxide concentrations in children, adolescents and adults.
During all protocols, participants will have their end-tidal gas concentrations measured and/or altered using prospective end-tidal gas targeting using a computer controlled gas blender system in which we have obtained Health Canada approval for.
Detailed description
The goal of this cross-sectional experimental study to determine the influence age, sex and pubertal status on cerebrovascular responses at rest and during isometric exercise.
The main objective is to investigate the regulatory mechanisms of cerebral blood flow during hypercapnia and isometric exercise, and determine whether any mechanistic differences in regulation are present with advancing age and maturation.
The following questions will be addressed in 20 healthy children (7-10 years), 20 healthy adolescents (12-16 years) and 20 young healthy adults (19-35 years), to compare the influence of age, sex and maturation on these responses, as follows:
- Investigate the brain blood flow responses to isometric exercise with and without hypercapnia (+9 mmHg carbon dioxide) in children, adolescents and adults.
- Investigate the brain blood flow responses to hypercapnia (+9 mmHg carbon dioxide) in children, adolescents and adults using a ramp incremental 4 minute protocol compared with a 30 second protocol, to identify which method is the most tolerable in children and adolescents.
- Determine whether sex, and the sex-dependent influences of age and maturation influence any of the brain blood flow responses to hypercapnia or isometric handgrip exercise.
To control and manipulate breathing gases during the study protocols, the partial pressures of end-tidal carbon dioxide and oxygen will be sampled at the mouth using the Investigational Testing Authorization approved computer controlled gas blender system. To target specific end-tidal carbon dioxide and oxygen levels during the clamped breathing and hypercapnic trials respectively, prospective end-tidal gas targeting will be utilized. The system allows for breath-by-breath regulation of end-tidal gases, independently of ventilation. End-tidal concentrations are prospectively targeted by controlling the inspired concentration of carbon dioxide and oxygen according to the previous expired breath, allowing this to be precisely controlled throughout the duration of the protocol. Gas analysis, and spirometry measures of tidal volume and breathing frequency will be recorded using the computer controlled system. Prospective end-tidal gas targeting is safe, with all inspired gases containing oxygen, with rigorous control procedures and fail-safe mechanisms which do not allow inhaled gases to fall outside of safe thresholds.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children (7-10 years) | – | Device: RespirACT RA-MR SystemAll groups of the experiment will be exposed to the same intervention. The intervention the participants are exposed to is the use of the computer controlled gas blender system for manipulation of end-tidal and arterial blood gases. This will be used for the following protocols, to either clamp end-tidal concentrations at resting levels or administer a hypercapnia challenge. The protocol includes assessment of cerebral blood flow responses (measured using ultrasound) to carbon dioxide; including a hypercapnia ramp protocol followed by a transient protocol. Following at least 30 minute wash out, participants will then perform isometric exercise at 30% of their maximal voluntary contraction for 2 minutes. Participants will perform the isometric handgrip exercise under 2 different conditions (hypercapnia (+9 mmHg) and clamped breathing; to maintain baseline end-tidal carbon dioxide and oxygen concentrations) with a 20-minute recovery period between each bout. |
| Adolescents (12-16 years) | – | Device: RespirACT RA-MR SystemAll groups of the experiment will be exposed to the same intervention. The intervention the participants are exposed to is the use of the computer controlled gas blender system for manipulation of end-tidal and arterial blood gases. This will be used for the following protocols, to either clamp end-tidal at resting levels or administer a hypercapnia challenge. The protocol includes assessment of cerebral blood flow responses (measured using ultrasound) to carbon dioxide; including a hypercapnia ramp protocol followed by a transient protocol. Following at least 30 minute wash out, participants will then perform isometric exercise at 30% of their maximal voluntary contraction for 2 minutes. Participants will perform the isometric handgrip exercise under 2 different conditions (hypercapnia (+9 mmHg) and clamped breathing; to maintain baseline end-tidal carbon dioxide and oxygen concentrations) with a 20-minute recovery period between each bout. |
| Adults (18-35 years) | – | Device: RespirACT RA-MR SystemAll groups of the experiment will be exposed to the same intervention. The intervention the participants are exposed to is the use of the computer controlled gas blender system for manipulation of end-tidal and arterial blood gases. This will be used for the following protocols, to either clamp end-tidal at resting levels or administer a hypercapnia challenge. The protocol includes assessment of cerebral blood flow responses (measured using ultrasound) to carbon dioxide; including a hypercapnia ramp protocol followed by a transient protocol. Following at least 30 minute wash out, participants will then perform isometric exercise at 30% of their maximal voluntary contraction for 2 minutes. Participants will perform the isometric handgrip exercise under 2 different conditions (hypercapnia (+9 mmHg) and clamped breathing; to maintain baseline end-tidal carbon dioxide and oxygen concentrations) with a 20-minute recovery period between each bout. |
Who may qualify
- Ages
- 7 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will be healthy children, adolescents and adults between the ages of 7-10 years, 12-16 years or 19-35 years of age. Participants will be recruited from the general population from online advertisements and media, targeting children, adolescents and adults residing in the Okanagan, British Columbia.
Key inclusion criteria (5 listed)
- Are aged between 7-10 years, 12-16 years or 19-35 years
- Male or Female
- Have a normal blood pressure (<160/110 mmHg) and are not taking any anti-hypertensive medications.
- No prior or current history of cardiorespiratory of cerebrovascular diseases.
- Can communicate in English
Key exclusion criteria (16 listed)
- Inability to perform handgrip exercise
- Are currently taking any medications known to influence vascular function, heart rate or blood pressure
- Have epilepsy
- Are a current smoker
- Have known cardiometabolic abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RespirACT RA-MR SystemRespirAct RA-MR™ is a computer-controlled gas blender to implement precise control of blood gases for a consistent and repeatable stimulus. | Device | Adolescents (12-16 years), Adults (18-35 years), Children (7-10 years) |
Primary outcome
Cerebral blood flow
Time frame: Experimental visit (1 day)
Ultrasound assessment of the internal carotid artery blood flow
7 secondary outcomes
Cerebral blood velocity
Time frame: Experimental visit (1 day)
Beat-by-beat blood pressure
Time frame: Experimental visit (1 day)
Saliva hormone concentrations
Time frame: Experimental visit (1 day)
Physical activity questionnaire
Time frame: Experimental visit (1 day)
Anthropometrics: weight
Time frame: Experimental visit (1 day)
Gas analysis
Time frame: Experimental visit (1 day)
Anthropometrics: height
Time frame: Experimental visit (1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Results publication: PubMed 18565992Ito S, Mardimae A, Han J, Duffin J, Wells G, Fedorko L, Minkovich L, Katznelson R, Meineri M, Arenovich T, Kessler C, Fisher JA. Non-invasive prospective targeting of arterial P(CO2) in subjects at rest. J Physiol. 2008 Aug 1;586(15):3675-82. doi: 10.1113/jphysiol.2008.154716. Epub 2008 Jun 19.
- Results publication: PubMed 27000209Fisher JA. The CO2 stimulus for cerebrovascular reactivity: Fixing inspired concentrations vs. targeting end-tidal partial pressures. J Cereb Blood Flow Metab. 2016 Jun;36(6):1004-11. doi: 10.1177/0271678X16639326. Epub 2016 Mar 21.
- Individual participant dataSharing planned: Yes. Pseudonymized data from this study will be made available for sharing with other investigators, after publication of the study's key papers. Data will be shared through the Federated Research Data Repository (FRDR) (https://www.frdr-dfdr.ca/repo/). This is a secure data repository, which is searchable on the www, it is managed by Library Services. A digital object identifier (DOI) will be generated for datasets as they are deposited to the repository. Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
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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.
Jared Baylis, MD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Regulation, run by University of British Columbia.
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 5 inclusion and 16 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ali McManus, PhD (250-807-9873, ali.mcmanus@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: Experimental visit (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06142045, which also lists 2 linked publications.
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 6 Mar 2024.