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Device

CO2 Rebreathing 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

Physician diagnosis of Neurogenic Orthostatic Hypotension

Must not have

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 hut - symptoms at the 5th minute of supine rest) will be compared between room air vs co2 rebreathe

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am 18 years old or older.

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I have been diagnosed with low blood pressure when standing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot climb stairs without feeling short of breath due to heart or lung problems.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Δ Blood Pressure (BP)

Secondary study objectives

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

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

0 / 3Eligibility criteria met