Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-26 @ 2:15 PM
Study NCT ID:
NCT05958303
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2023-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HYPEROXIA Responses and ROS
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
30 participants (15 males and 15 females) who are ≥18 - ≤ 40 years old and considered healthy will be enrolled into this study to test the role of reactive oxygen species (ROS) in regulating cerebral blood flow (CBF). Participants can expect to be on study for 2 study visits over a 6 month period.
Detailed Description:
Objective: The current objective is to determine whether biological sex influences CBF control in hyperoxia in healthy young adults without confounds of age or disease.
The investigators will address 3 specific questions:
1. Are cerebral vasoconstrictor responses to hyperoxia greater in men?
2. Do all brain regions respond equally, or are there regional differences-possibly varying by sex?
3. Do ROS regulate the decrease in CBF in a sex specific fashion?
This study will be conducted in compliance with federal investigational drug regulations (21 CFR 312) and Good Clinical Practice (GCP) guidelines, as well as state law and institutional policies.
Study Population: This study includes 30 total participants; (15 males and 15 females) who are ≥18 - ≤ 40 years old and considered healthy.
Approach: CBF testing will be performed in research-dedicated MRI systems on UW campus. Participants will experience normoxia followed by hyperoxia conditions during each of the 2 study visits. Study design focuses on the use of an acute oral antioxidant cocktail (AOC) to test ROS signaling as a potential mechanism explaining sex differences in CBF control. To do this, 2 MRI visits in a double-blind placebo-controlled design will be conducted.
The investigators will address 3 specific questions:
1. Are cerebral vasoconstrictor responses to hyperoxia greater in men?
2. Do all brain regions respond equally, or are there regional differences-possibly varying by sex?
3. Do ROS regulate the decrease in CBF in a sex specific fashion?
This study will be conducted in compliance with federal investigational drug regulations (21 CFR 312) and Good Clinical Practice (GCP) guidelines, as well as state law and institutional policies.
Study Population: This study includes 30 total participants; (15 males and 15 females) who are ≥18 - ≤ 40 years old and considered healthy.
Approach: CBF testing will be performed in research-dedicated MRI systems on UW campus. Participants will experience normoxia followed by hyperoxia conditions during each of the 2 study visits. Study design focuses on the use of an acute oral antioxidant cocktail (AOC) to test ROS signaling as a potential mechanism explaining sex differences in CBF control. To do this, 2 MRI visits in a double-blind placebo-controlled design will be conducted.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HL150361-01 | NIH | None | https://reporter.nih.gov/quic… | View |
| EDUC/KINESIOLOGY | OTHER | UW Madison | View | |
| Protocol Version 2/27/2024 | OTHER | UW Madison | View |