CompletedNot Applicable

HYPEROXIA Responses and ROS

United States24 participantsStarted 2024-07-24

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Copper intrauterine devices (IUDs) will be allowed as they do not change systemic sex hormone levels).
. Women currently taking hormonal birth control (i.e. contraceptive pills, patch, ring) for contraception only (not for a medical condition such as those listed in exclusion criteria above) may consider temporarily stopping to become eligible for enrollment. Hormonal birth control must be stopped at least one month prior to Study Visit 1 to provide time for menstruation to resume. Then stoppage continues through the last planned study visit. Screening information will be reviewed by endocrinology physicians to determine eligibility and timing on this issue (details below).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial looked at how breathing high levels of oxygen affects blood flow in the brain differently in men versus women — could those findings be relevant to my specific cerebrovascular condition, and should I ask to have my cerebral blood flow measured?
2Since this trial has already been completed, has my doctor seen or heard anything about its results, and do the findings change how they think about oxygen therapy or brain blood flow management in my care?
3The study measured blood flow in specific lobes of the brain during normal and high-oxygen conditions — does my condition affect particular brain regions where these kinds of blood flow differences might actually matter for my treatment?
4Because this was a completed research study rather than a treatment trial, are there follow-up clinical trials building on these findings that might be more directly relevant to my situation and worth considering?
5If there turn out to be meaningful sex-based differences in how the brain responds to oxygen, could that affect any current or future treatment decisions my doctor might make for me specifically?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cerebral Blood Flow in Normoxia, Male vs Female

Timeframe: up to 6 months

Cerebral Blood Flow in Hyperoxia, Male vs Female

Timeframe: up to 6 months

Lobar Cerebral Blood Flow in Normoxia, Male vs Female

Timeframe: up to 6 months

Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female

Timeframe: up to 6 months

Trial details

NCT IDNCT05958303

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

Results submitted2026-03-31

View on ClinicalTrials.gov More Cerebrovascular Disorders trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Copper intrauterine devices (IUDs) will be allowed as they do not change systemic sex hormone levels).
. Women currently taking hormonal birth control (i.e. contraceptive pills, patch, ring) for contraception only (not for a medical condition such as those listed in exclusion criteria above) may consider temporarily stopping to become eligible for enrollment. Hormonal birth control must be stopped at least one month prior to Study Visit 1 to provide time for menstruation to resume. Then stoppage continues through the last planned study visit. Screening information will be reviewed by endocrinology physicians to determine eligibility and timing on this issue (details below).

What they're measuring

Cerebral Blood Flow in Normoxia, Male vs Female

Timeframe: up to 6 months

Cerebral Blood Flow in Hyperoxia, Male vs Female

Timeframe: up to 6 months

Lobar Cerebral Blood Flow in Normoxia, Male vs Female

Timeframe: up to 6 months

Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female

Timeframe: up to 6 months