NCT06751888: CO2-nOH

Controlled CO2 Inhalation in NOH

Not yet recruiting NA Last updated 30 December 2024

What this trial tests

NA trial testing Controlled CO2 delivery in Neurogenic Orthostatic Hypotension in 28 participants. Not yet recruiting.

Timeline

1 May 2025

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	University of Calgary
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	28
Start date	1 May 2025
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across Canada

Drugs / interventions tested

• Controlled CO2 delivery
• Controlled CO2 delivery (Sham)

Conditions studied

• Neurogenic Orthostatic Hypotension — all drugs for Neurogenic Orthostatic Hypotension →

Sponsor

University of Calgary

Who can join

18 and older, any sex, with Neurogenic Orthostatic Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study focuses on neurogenic orthostatic hypotension (nOH), which is a disorder characterized by an abnormal drop in blood pressure (BP) within 3-minutes of standing. Patients with nOH experience debilitating symptoms including light-headedness, falls, and fainting. Patients often struggle with day-to-day tasks that require standing, with a reduced quality-of-life. Current therapies for nOH have limited effectiveness and unwanted side effects. Our lab has found that raising blood CO2 levels (hypercapnia) in the lab increases BP when standing in patients with nOH. We now aim to test the CarboHaler, an exogenous controlled CO2 delivery device, in this study to see if increasing CO2 levels through controlled CO2 inhalation can improve BP and reduce symptoms in patients with nOH when standing up. On the study day, participants will undergo two Head-up Tilt (HUT; upright) tests with different breathing protocols: one with and one without exogenous CO2 delivery provided by a CO2 inhalational device. We will record heart rate, blood pressure, and breathing parameters. We will also assess upright symptoms using the Vanderbilt Orthostatic Symptoms Score. Our primary outcome is the magnitude of the change in systolic BP from lying down to standing, which will be compared with and without exogenous CO2 delivery. We hypothesize that exogenous CO2 delivery provided by a CO2 inhalational device will raise CO2 enough to increase standing BP, which could reduce the debilitating symptoms experienced by patients with nOH. We hope that these data will support future clinical trials, with the long-term goal of creating a simple, low-cost treatment for increasing quality-of-life for patients with nOH.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.