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NCT Number: NCT06261034

A Study of Sex Differences in Neurocirculatory Control

The purpose of this study is to investigate potential sex differences in neurocirculatory control of blood pressure in patients with untreated obstructive sleep apnea (OSA).

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

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

Inclusion criteria

  • 20-70 years of age

Exclusion criteria

  • Coronary artery disease
  • Heart failure
  • Pregnancy
  • COPD
  • Diabetes
  • CKD
  • Sleep disorders other than OSA
  • Shift workers
  • Individuals who typically go to sleep after midnight
  • Individuals who traveled across ≥2 time zones within one week of study visits
  • BMI ≥40.0kg/m2
  • Use of nicotine-containing products within the two years preceding study visits
  • Use of allopurinol, proton pump inhibitors, or other medications/supplements which interfere with outcome measures

Treatment and study plan

Primary outcomes

  1. Blood pressure

    Time frame: Baseline

    Measured in millimeters of mercury (mmHg).

  2. Arterial stiffness

    Time frame: Baseline

    Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec)

  3. Endothelial function

    Time frame: Baseline

    Ultrasound assessment of flow-mediated vasodilation of the brachial artery. Brachial artery diameter and blood velocity will be measured after deflation to measure endothelial function.

Secondary outcomes

  1. Sympathetic nerve burst frequency

    Time frame: Baseline

    Measured by Microneurography reported as number of nerve bursts per minute (burst/min)

  2. Sympathetic nerve burst incidence

    Time frame: Baseline

    Measured by Microneurography reported as number of nerve burst per 100 heart beats (burst/100 heart beats)

  3. Sympathetic nerve burst amplitude (AU)

    Time frame: Baseline

    Measured by Microneurography reported in arbitrary units (AU)

  4. Total muscle sympathetic nerve activity (MSNA)

    Time frame: Baseline

    Measured by Microneurography reported burst arbitrary units per minute (AU/min)

Other outcomes

  1. Cerebral autoregulation

    Time frame: Baseline

    Measured by transcranial doppler ultrasound (cm/sec).

  2. Sympathetic action potentials per burst

    Time frame: Baseline

    Measured by Microneurography reported as action potentials per burst (reflecting firing rate).

  3. Sympathetic action potential clusters per burst

    Time frame: Baseline

    Measured by Microneurography reported as clusters per burst (reflecting recruitment of latent subpopulations).

  4. Sympathetic action potential conduction latency of each cluster

    Time frame: Baseline

    Measured by Microneurography reported as conduction latency of each cluster (reflecting synaptic delays and verifying larger amplitude clusters as new populations).

  5. Immune function

    Time frame: Baseline

    Immune function will be measured as percent of parent cell population.

  6. Urinary Extracellular Vesicle Presence and Content

    Time frame: Baseline

    Number of extracellular vesicles present in a 24 hour urine collection and the contents being carried by those vesicles.

  7. Plasma Extracellular Vesicle Presence and Content

    Time frame: Baseline

    Number of extracellular vesicles present in blood plasma sample and the contents being carried by those vesicles.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Sex Differences in Neurocirculatory Control With Obstructive Sleep Apnea

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 15, 2024
Registry last updated
Jan 7, 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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