A Study of Sex Differences in Neurocirculatory Control

Obstructive Sleep Apnea Clinical Trial

Official title:

Sex Differences in Neurocirculatory Control With Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261034
• Other study ID #: 23-008765
• Secondary ID: 8K12AR084222-15
• Status: Recruiting
• Start date: July 2024
• Est. completion date: March 2027

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: Joshua Bock, PhD
• Phone: (507) 422-0768
• Email: Bock.Joshua[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral autoregulation	Measured by transcranial doppler ultrasound (cm/sec).	Baseline
Other	Sympathetic action potentials per burst	Measured by Microneurography reported as action potentials per burst (reflecting firing rate).	Baseline
Other	Sympathetic action potential clusters per burst	Measured by Microneurography reported as clusters per burst (reflecting recruitment of latent subpopulations).	Baseline
Other	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
Other	Immune function	Immune function will be measured as percent of parent cell population.	Baseline
Other	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
Other	Plasma Extracellular Vesicle Presence and Content	Number of extracellular vesicles present in blood plasma sample and the contents being carried by those vesicles.	Baseline
Primary	Blood pressure	Measured in millimeters of mercury (mmHg).	Baseline
Primary	Arterial stiffness	Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec)	Baseline
Primary	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	Sympathetic nerve burst frequency	Measured by Microneurography reported as number of nerve bursts per minute (burst/min)	Baseline
Secondary	Sympathetic nerve burst incidence	Measured by Microneurography reported as number of nerve burst per 100 heart beats (burst/100 heart beats)	Baseline
Secondary	Sympathetic nerve burst amplitude (AU)	Measured by Microneurography reported in arbitrary units (AU)	Baseline
Secondary	Total muscle sympathetic nerve activity (MSNA)	Measured by Microneurography reported burst arbitrary units per minute (AU/min)	Baseline