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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)

Must not have

Diagnosed sleep apnea or Oxygen desaturation index >10 events/hr

Pregnancy, breastfeeding, oral hormonal contraceptive use

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I have sleep apnea or my oxygen levels drop frequently at night.

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I am not pregnant, breastfeeding, or using oral hormonal contraceptives.

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I have a nerve or neurological condition.

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I am allergic to lidocaine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuous measurement of vascular conductance during infusion of each drug (final 3 min of normoxia and hypoxia).

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

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

Primary study objectives

Change in forearm vascular conductance with intra-arterial drug infusion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2040