Reflex Responses to Intermittent Hypoxia in Humans: Mechanisms and Consequences
NCT ID: NCT05146089
Last Updated: 2021-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
54 participants
INTERVENTIONAL
2016-12-20
2021-04-12
Brief Summary
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Detailed Description
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Intermittent hypoxia (IH) has been implicated in animal models as the primary stimulus for evoking increases in sympathetic activity with recurrent apneas. Thus, the overall goal of this application is to better understand the effect of IH on sympathetic discharge patterns in humans as well as the mechanisms mediating persistent sympathoexcitation with IH. By better understanding the effect of IH on sympathoexcitation, targeted therapeutic approaches might be devised to mitigate the effects of sympathetic over-activity on the cardiovascular system in conditions such as sleep apnea.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Hypoxia Exposure
Men and women will be exposed to acute intermittent hypoxic episodes.
Hypoxic exposure
30 minutes of intermittent hypoxia achieved using breaths of low oxygen air (5% oxygen) followed by room air through a mask.
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.
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.
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.
Interventions
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Hypoxic exposure
30 minutes of intermittent hypoxia achieved using breaths of low oxygen air (5% oxygen) followed by room air through a mask.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 18-45 years of age;
* BMI \<30 kg/m2;
* non-pregnant/non-breastfeeding;
* non-smokers.
Exclusion Criteria
* taking any medications known to affect the cardiovascular or autonomic nervous system (e.g. alpha-blockers, beta-blockers, etc);
* Apnea Hypopnea Index \>10 events/hr
Self-reported history of:
* hepatic, renal, pulmonary, cardiovascular, or neurological disease;
* stroke or neurovascular disease;
* bleeding/clotting disorders;
* sleep apnea or other sleep disorders;
* diabetes;
* smoking;
* history of alcoholism or substance abuse;
* hypertension.
18 Years
45 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Mayo Clinic
OTHER
University of Missouri-Columbia
OTHER
Responsible Party
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Jacqueline K Limberg, PhD
Assistant Professor
Principal Investigators
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Jacqueline K Limberg, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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University of Missouri-Columbia
Columbia, Missouri, United States
Mayo Clinic
Rochester, Missouri, United States
Countries
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Other Identifiers
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