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Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity
Patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. Contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. This project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.
Conditions:
🦠 Obesity 🦠 Healthy 🦠 Vasoconstriction 🦠 Vasodilation
🗓️ Study Start (Actual) 9 December 2020
🗓️ Primary Completion (Estimated) 30 June 2025
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 104
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Columbia, Missouri, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 18-45 years of age (premenopausal)
    • * Healthy weight (BMI ≥18 and ≤25 kg/m2)
    • * Obese (BMI ≥30 kg/m2)

    Exclusion Criteria:

    • * Pregnancy, breastfeeding, oral hormonal contraceptive use
    • * Diagnosed sleep apnea or Oxygen desaturation index \>10 events/hr
    • * Current smoking/Nicotine use
    • * Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
    • * Nerve/neurologic disease
    • * Cardiovascular, hepatic, renal, respiratory disease
    • * Blood pressure ≥140/90 mmHg
    • * Diabetes, Polycystic ovarian syndrome
    • * Communication barriers
    • * Prescription medications, Sensitivity to lidocaine
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 June 2020
  • First Submitted that Met QC Criteria 15 June 2020
  • First Posted 18 June 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 May 2024
  • Last Update Posted 3 May 2024
  • Last Verified May 2024
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