Reflex Responses to Intermittent Hypoxia in Humans: Mechanisms and Consequences
NCT05146089 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2021-12-06
Summary
The overall goal of this project is to better understand the effect of intermittent hypoxia (IH) on sympathetic neuronal discharge patterns in humans, as well as mechanisms that mediate persistent sympathoexcitation with IH.
Conditions
- Sleep Apnea
- Healthy
- Vasoconstriction
- Vasodilation
Interventions
- OTHER
-
Hypoxic exposure
30 minutes of intermittent hypoxia achieved using breaths of low oxygen air (5% oxygen) followed by room air through a mask.
- OTHER
-
modified Oxford test
An intravenous bolus of sodium nitroprusside (100 μg) will be given to decrease blood pressure, followed 1 minute later by a bolus of phenylephrine (150 μg) to increase blood pressure, occurring before and after intermittent hypoxia exposure.
- DRUG
-
Oral Bosentan 62.5 mg
Prior to completion of visit 2, male subjects will consume 62.5 mg twice daily for 3 days as well as the morning of the study visit (7 pills) at home and experimental sessions will be performed 3 hours after oral intake of the final dose.
- OTHER
-
Hypoxic ventilatory response test
Hypoxia will be achieved using breaths of low oxygen air (5% oxygen) followed by room air through a mask. This will be repeated 4-5 times per test, occurring before and after intermittent hypoxia exposure.
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH - collaborator OTHER
-
University of Missouri-Columbia
lead OTHER
Principal Investigators
-
Jacqueline K Limberg, Ph.D. · University of Missouri-Columbia
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-12-20
- Primary Completion
- 2018-09-08
- Completion
- 2021-04-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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