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Sleep Apnea's Cardiovascular Impact on Women With Obesity

Phase < 1
Recruiting
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese (BMI ≥30 kg/m2)
18-45 years of age (premenopausal)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuous measurement of vascular conductance during infusion of each drug (final 3 min of normoxia and hypoxia).
Awards & highlights

Study Summary

This trial looks at how sleep apnea affects cardiovascular disease in women, who may be at greater risk than men.

Who is the study for?
This trial is for premenopausal women aged 18-45, who are either obese (BMI ≥30) or of healthy weight (BMI between 18 and ≤25). Participants should not have sleep apnea, cardiovascular issues, clotting disorders, high blood pressure, diabetes, PCOS, communication barriers or be using certain medications including oral contraceptives.Check my eligibility
What is being tested?
The study investigates how low oxygen levels affect the cardiovascular system differently in men and women and if obesity influences this. It involves drugs like Phentolamine and Norepinephrine to study blood vessel responses under hypoxic conditions.See study design
What are the potential side effects?
Potential side effects may include changes in blood pressure or heart rate due to the drugs used to manipulate vascular responses. Hypoxia exposure might cause shortness of breath or lightheadedness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is 30 or higher.
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I am between 18 and 45 years old and have not gone through menopause.
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My BMI is between 18 and 25.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuous measurement of vascular conductance during infusion of each drug (final 3 min of normoxia and hypoxia).
This trial's timeline: 3 weeks for screening, Varies for treatment, and continuous measurement of vascular conductance during infusion of each drug (final 3 min of normoxia and hypoxia). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in forearm vascular conductance with intra-arterial drug infusion

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hypoxia ExposureExperimental Treatment5 Interventions
A physician will place a catheter in the brachial artery for intra-arterial pharmacological infusions. The following drugs will be administered to each participant under room air (normoxic) and low oxygen (hypoxic) conditions: phenylephrine, dexmedetomidine, norepinephrine, phentolamine (see Interventions for details).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Norepinephrine
2014
Completed Phase 4
~1780
Phenylephrine
2014
Completed Phase 4
~2050
Dexmedetomidine
2015
Completed Phase 4
~1980

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,010 Total Patients Enrolled
20 Trials studying Obesity
2,098 Patients Enrolled for Obesity

Media Library

Hypoxia Exposure Clinical Trial Eligibility Overview. Trial Name: NCT04436731 — Phase < 1
Obesity Research Study Groups: Hypoxia Exposure
Obesity Clinical Trial 2023: Hypoxia Exposure Highlights & Side Effects. Trial Name: NCT04436731 — Phase < 1
Hypoxia Exposure 2023 Treatment Timeline for Medical Study. Trial Name: NCT04436731 — Phase < 1
Obesity Patient Testimony for trial: Trial Name: NCT04436731 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this exploration accept participants aged 70 and above?

"To be considered for this trial, candidates must have a chronological age between 18 and 45 years old. Conversely, there are 286 trials recruiting minors below the age of 18 and 1050 studies that accept elderly participants aged 65 or above."

Answered by AI

What medical ailments can be treated with Hypoxia Exposure?

"Hypoxia Exposure is a well-known and effective treatment for pupil, as well as catarrh, rhinorrhoea, and pheochromocytomas."

Answered by AI

Could I be a potential participant in this clinical experiment?

"This trial is seeking 104 people with vasoconstriction who are between ages 18 and 45. Criteria for eligible participants includes being overweight (BMI ≥30 kg/m2), pre-menopausal, and of a healthy weight range (BMI ≥18 to ≤25 kg/m2)."

Answered by AI

Does this research endeavor require additional participants at the present time?

"Affirmative, according to information posted on clinicialtrials.gov, this medical experiment is actively accepting participants. The trial was initially advertised on December 9th 2020 and its details have been modified as recently as February 3rd 2022. In total, 104 individuals are needed at one particular site for the study's completion."

Answered by AI

Has Hypoxia Exposure been tested in any other clinical investigations?

"At present, 149 studies exploring Hypoxia Exposure are currently taking place with 31 trials in the third phase. The majority of these experiments are located in Caxias do Sul, Rio Grande do Sul; however, 273 sites worldwide have clinical trial operations for Hypoxia Exposure."

Answered by AI

What is the uppermost limit of individuals participating in this research?

"Affirmative. According to the information shared on clinicaltrials.gov, this research trial is actively seeking out volunteers and was first posted on December 9th 2020. It requires 104 individuals from a single site for participation in its activities."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
University of Missouri-Columbia
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've been trying for 20+ years to lose weight...fad diets, exercise, lifestyle changes, doctors, weight loss programs, pills, etc. Some methods worked better than others but I have never come close to achieving my goal weight. While I have been able to lose over 100lbs over a 4 year period, I am still struggling, and am, in fact, gaining again. The excess weight is affecting my daily life like it never has before.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity
Jacqueline K Limberg, PhD 2020. "Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04436731.
~27 spots leftby Jun 2025
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