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Device
CO2 Rebreathing for Orthostatic Hypotension
N/A
Waitlist Available
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
Physician diagnosis of Neurogenic Orthostatic Hypotension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the δ vanderbilt orthostatic symptom score (symptoms at the 5th minute of hut - symptoms at the 5th minute of supine rest) will be compared between room air vs co2 rebreathe
Awards & highlights
Study Summary
This trial is testing if using a CO2 rebreather device can reduce symptoms of neurogenic orthostatic hypotension, a condition associated with cardiovascular risk & reduced quality of life. Results will show if the device increases CO2 enough to improve BP.
Who is the study for?
This trial is for adults over 18 with neurogenic orthostatic hypotension (nOH), who don't smoke and can travel to the University of Calgary. It's not for those with severe heart or lung issues, other illnesses affecting autonomic function, substance abuse problems, pregnant or breastfeeding women, or anyone on medications that could affect test results.Check my eligibility
What is being tested?
The study tests a CO2 rebreather device as a potential treatment for nOH by having participants use it during a head-up tilt test. The goal is to see if re-inhaling CO2 can help improve their blood pressure when they stand up.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information but may include discomfort from using the rebreathing device and possible dizziness or lightheadedness due to changes in blood pressure during testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with low blood pressure when standing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the δ vanderbilt orthostatic symptom score (symptoms at the 5th minute of hut - symptoms at the 5th minute of supine rest) will be compared between room air vs co2 rebreathe
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the δ vanderbilt orthostatic symptom score (symptoms at the 5th minute of hut - symptoms at the 5th minute of supine rest) will be compared between room air vs co2 rebreathe
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Δ Blood Pressure (BP)
Secondary outcome measures
Δ Cerebral Blood Flow Velocity (CBFv)
Δ Vanderbilt Orthostatic Symptom Score [Range: 0 (absent) to 10 (worst)]
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CO2 RebreathingExperimental Treatment1 Intervention
Participants will breathe with the rebreather in the supine position until CO2 levels increase between 5-10mmHg. Once CO2 levels are increased, participants will be tilted upright, and will continue to breathe with the rebreather during a 5-min HUT test
Group II: Room AirActive Control1 Intervention
Participants will breathe room air in the supine position and during a 5-min HUT test
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,126 Total Patients Enrolled
Satish R Raj, MDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People who do not smoke.I am either male or female.I do not have conditions like dementia, substance abuse, or major organ disease that could affect my study participation.I am not on medications that affect nerve function tests.I cannot climb stairs without feeling short of breath due to heart or lung problems.I am 18 years old or older.I have been diagnosed with low blood pressure when standing.
Research Study Groups:
This trial has the following groups:- Group 1: Room Air
- Group 2: CO2 Rebreathing
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the status of participant enrollment for this experiment?
"According to clinicaltrials.gov, this research project has completed the recruitment of participants and is no longer accepting applications. The trial was initially posted on September 1st 2023 and last updated on June 8th 2023. However, there are 133 other studies that remain open for enrollment at this moment in time."
Answered by AI
What are the eligibility requirements to participate in this trial?
"To meet the eligibility requirements of this trial, individuals should have autonomic failure and span between 18 to 100 years old. The organisers are in search of 28 participants."
Answered by AI
Are seniors being included in the subject pool of this research endeavor?
"People aged 18 to 100 may enrole in this clinical trial. Separately, there are 7 trials specifically for those younger than 18 and 107 studies reserved for individuals above the age of 65."
Answered by AI
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