NCT05256069

Brief Summary

The purpose of this project is to identify sex-related differences in the effect of hypoxia on sympathetic vascular transduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2023

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 26, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

February 14, 2022

Last Update Submit

September 8, 2025

Conditions

VasodilationHypoxia

Outcome Measures

Primary Outcomes (1)

  • Forearm Blood Flow

    Measured with venous occlusion plethysmography (mL/dL/min)

    Change from baseline to 5 minutes

Study Arms (1)

Hypoxia Exposure

EXPERIMENTAL

Men and women will be exposed to isocapnic hypoxia. Participants will wear a mask and systemic oxygen levels will be titrated to attain hypoxemia as assessed by pulse oximetry.

Drug: Propranolol PillDrug: Placebo

Interventions

Propranolol PillDRUG

Participants will receive a β-blockade (propranolol pill, 1 mg/kg dosed based on participant weight).

Hypoxia Exposure
PlaceboDRUG

Participants will receive a placebo in pill form.

Hypoxia Exposure

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adult men and women;
  • years of age;
  • BMI 18-30 kg/m2;
  • non-pregnant/non-breastfeeding;
  • non-nicotine users;

You may not qualify if:

  • Pregnancy, breastfeeding, hormonal contraceptives
  • Diagnosed sleep apnea
  • Current smoking/Nicotine use/drug use
  • Nerve/neurologic disease
  • Cardiovascular, hepatic, renal, respiratory disease
  • Blood pressure ≥140/90 mmHg
  • Diabetes, Polycystic ovarian syndrome
  • Communication barriers
  • Prescription medications
  • Recent COVID-19 diagnosis with symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

AneurysmHypoxia

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Jacqueline K Limberg, Ph.D.

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 14, 2022

First Posted

February 25, 2022

Study Start

April 26, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations

US(1)