NCT06261034

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Oct 2024Mar 2027

First Submitted

Initial submission to the registry

February 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

October 29, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

February 7, 2024

Last Update Submit

January 6, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Sympathetic nerve burst frequency

    Baseline

  • Sympathetic nerve burst incidence

    Baseline

  • Sympathetic nerve burst amplitude (AU)

    Baseline

  • Total muscle sympathetic nerve activity (MSNA)

    Baseline

Other Outcomes (7)

  • Cerebral autoregulation

    Baseline

  • Sympathetic action potentials per burst

    Baseline

  • Sympathetic action potential clusters per burst

    Baseline

  • +4 more other outcomes

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Joshua Bock, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Bock, PhD

CONTACT

Ian Greenlund, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 15, 2024

Study Start

October 29, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations