A Study of Sex Differences in Neurocirculatory Control

Sex Differences in Neurocirculatory Control With Obstructive Sleep Apnea

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).

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Joshua Bock, PhD; Phone Number: (507) 422-0768; Email: bock.joshua@mayo.edu
• Study Contact Backup: Name: Ian Greenlund, PhD; Phone Number: (507) 422-3411; Email: Greenlund.Ian@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Joshua Bock, PhD; Phone Number: (507) 422-0768; Email: bock.joshua@mayo.edu
      • Contact: Ian Greenlund, PhD; Phone Number: (507) 422-3411; Email: Greenlund.Ian@mayo.edu
      • Principal Investigator: Joshua Bock, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects with or without untreated obstructive sleep apnea will be recruited from Mayo Clinic in Rochester, MN.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Measured in millimeters of mercury (mmHg).	Baseline
Arterial stiffness	Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec)	Baseline
Endothelial function	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sympathetic nerve burst frequency	Measured by Microneurography reported as number of nerve bursts per minute (burst/min)	Baseline
Sympathetic nerve burst incidence	Measured by Microneurography reported as number of nerve burst per 100 heart beats (burst/100 heart beats)	Baseline
Sympathetic nerve burst amplitude (AU)	Measured by Microneurography reported in arbitrary units (AU)	Baseline
Total muscle sympathetic nerve activity (MSNA)	Measured by Microneurography reported burst arbitrary units per minute (AU/min)	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral autoregulation	Measured by transcranial doppler ultrasound (cm/sec).	Baseline
Sympathetic action potentials per burst	Measured by Microneurography reported as action potentials per burst (reflecting firing rate).	Baseline
Sympathetic action potential clusters per burst	Measured by Microneurography reported as clusters per burst (reflecting recruitment of latent subpopulations).	Baseline
Sympathetic action potential conduction latency of each cluster	Measured by Microneurography reported as conduction latency of each cluster (reflecting synaptic delays and verifying larger amplitude clusters as new populations).	Baseline
Immune function	Immune function will be measured as percent of parent cell population.	Baseline
Urinary Extracellular Vesicle Presence and Content	Number of extracellular vesicles present in a 24 hour urine collection and the contents being carried by those vesicles.	Baseline
Plasma Extracellular Vesicle Presence and Content	Number of extracellular vesicles present in blood plasma sample and the contents being carried by those vesicles.	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Joshua Bock, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 23-008765; 8K12AR084222-15 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No