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OpenTrials
Completed

NCT Number: NCT04436731

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold pressor test

Other

Participants will complete the cold pressor test during the final 2 min of normoxia and hypoxia.

Primary outcomes

  1. Change in forearm vascular conductance with cold pressor test

    Time frame: Continuous measurement of vascular conductance during cold pressor test (final 2 min of normoxia and hypoxia).

    Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2020
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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