A Study of Sex Differences in Neurocirculatory Control

Recruiting

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT06261034
• Lead Sponsor: Mayo Clinic

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-15
• Study Start: 2024-10-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States