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Gas Delivery
Carbon Dioxide Breathing for Orthostatic Hypotension
N/A
Recruiting
Led By Satish R Raj, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Be older than 18 years old
Must not have
Subjects who require portable oxygen at rest or with exercise
Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the δ vanderbilt orthostatic symptom score (symptoms at the 5th minute of stand - symptoms at the 5th minute of sit) will be compared between room air and +10mmhgco2/50mmhg o2
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if breathing in carbon dioxide can help people with Neurogenic Orthostatic Hypotension, a condition where the "fight-or-flight" part of the nervous system fails.
Who is the study for?
This trial is for adults over 18 who can consent, travel to the University of Calgary, and are non-smokers. It's not for those with dementia, substance abuse issues, severe organ diseases, pregnant or breastfeeding women, people on certain medications affecting autonomic function or unable to wear a mask.
What is being tested?
The study tests if breathing in higher levels of carbon dioxide (Sequential Gas Delivery) can help manage low blood pressure when standing in patients with Neurogenic Orthostatic Hypotension by increasing blood pressure and brain blood flow.
What are the potential side effects?
Potential side effects may include discomfort from wearing a mask to deliver the gas and possible short-term changes in respiratory patterns due to increased carbon dioxide inhalation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need portable oxygen for breathing, either at rest or during physical activity.
Select...
I cannot climb stairs without feeling short of breath due to heart or lung problems.
Select...
I do not have conditions like dementia, substance abuse, stroke, kidney or liver disease, or surgeries affecting my nervous system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the δ vanderbilt orthostatic symptom score (symptoms at the 5th minute of stand - symptoms at the 5th minute of sit) will be compared between room air and +10mmhgco2/50mmhg o2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the δ vanderbilt orthostatic symptom score (symptoms at the 5th minute of stand - symptoms at the 5th minute of sit) will be compared between room air and +10mmhgco2/50mmhg o2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Bronchial Provocation Tests
Δ Cerebral Blood Flow Velocity (CBFv)
Δ Vanderbilt Orthostatic Symptom Score [Range: 0 (absent) to 10 (worst)]
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: +5mmHg CO2Experimental Treatment1 Intervention
All participants will complete an active stand breathing +5mmHg of CO2 relative to baseline
Group II: +10mmHg CO2 + 50mmHg O2Experimental Treatment1 Intervention
All participants will complete an active stand breathing +10mmHg of CO2 relative to baseline and 50mmHg of O2
Group III: +10mmHgExperimental Treatment1 Intervention
All participants will complete an active stand breathing +10mmHg of CO2 relative to baseline
Group IV: +0mmHg CO2 Clamped at baselineExperimental Treatment1 Intervention
All participants will complete an active stand with their CO2 held constant at baseline
Group V: Room AirActive Control1 Intervention
All participants will complete an active stand breathing room air with CO2 free to fluctuate
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,303 Total Patients Enrolled
Satish R Raj, MDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
48 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe anxiety or somatization symptoms.I need portable oxygen for breathing, either at rest or during physical activity.I cannot climb stairs without feeling short of breath due to heart or lung problems.I am 18 years old or older.I am either male or female.I do not have conditions like dementia, substance abuse, stroke, kidney or liver disease, or surgeries affecting my nervous system.People who do not smoke.I am not on medications that affect nerve function tests.You cannot wear a mask for the whole study.
Research Study Groups:
This trial has the following groups:- Group 1: Room Air
- Group 2: +0mmHg CO2 Clamped at baseline
- Group 3: +5mmHg CO2
- Group 4: +10mmHg
- Group 5: +10mmHg CO2 + 50mmHg O2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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