Procedure

Controlled CO2 Inhalation for Neurogenic Orthostatic Hypotension (CO2-nOH Trial)

Calgary, Canada

N/A

Waitlist Available

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

Pregnant or breast-feeding females

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of in-lab study day to the end of the in-lab study day

Summary

"This trial aims to test a new device called CarboHaler for patients with neurogenic orthostatic hypotension (nOH). This condition causes a sudden drop in blood pressure when standing up

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Who is the study for?

This trial is for individuals with neurogenic orthostatic hypotension (nOH), a condition causing blood pressure to drop when standing, leading to dizziness and fainting. Participants should have nOH symptoms and be able to undergo Head-up Tilt tests. Specific inclusion and exclusion criteria details are not provided.Check my eligibility

What is being tested?

The study is testing the CarboHaler, a device that delivers controlled CO2, to see if it can improve blood pressure and reduce symptoms in nOH patients when they stand up. The effect of CO2 inhalation on systolic BP from lying down to standing will be measured.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort or respiratory changes due to CO2 inhalation; these will be monitored during the trial.

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 a condition that causes low blood pressure when standing.

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Exclusion Criteria

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

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

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I am not pregnant or breastfeeding.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of in-lab study day to the end of the in-lab study day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of in-lab study day to the end of the in-lab study day

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of in-lab study day to the end of the in-lab study day for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Magnitude of the systolic blood pressure (SBP) response

Secondary study objectives

Change in Cerebral Blood Flow (ΔCBFv)

Change in Vanderbilt Orthostatic Symptom Scores (ΔVOSS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Controlled CO2 Inhalation ArmExperimental Treatment1 Intervention

In this arm, participants will breathe with the CO2 delivery device in the supine position until BP levels increase. Once a BP increase is observed, participants will be tilted upright and will continue to breathe with the inhalation device during a 10-min HUT test.

Group II: 0% CO2 ArmPlacebo Group1 Intervention

In this arm, participants will breathe with the CO2 delivery device providing no exogenous CO2 while supine and during a 10-min HUT test.

0 / 4Eligibility criteria met