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Completed

NCT Number: NCT05001048

Sex Differences in Sympathetic Activity and Vascular Reactivity During Acute and Chronic Hypoxia.

This study aims to investigate sex differences in blood pressure control associated with exposure to acute hypoxia (low oxygen), and short term acclimatization to hypoxia at high altitude.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Royal University, Calgary, Alberta, Canada

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About this study

About 200 million people worldwide live at high altitudes. Millions of others travel to high altitude every year for work or travel. The low oxygen (or hypoxia) experienced at high altitudes causes considerable physiological stress, and the body adapts in order to maintain adequate oxygen delivery to its tissues. One of these adaptations is an increase in the activity of the sympathetic nervous system. This system is responsible for the "fight or flight" response. Sympathetic activity regulates the size of the blood vessels, which will affect blood pressure. Previous studies suggest that males and females regulate their blood pressure in different ways. Females tend to have lower resting sympathetic activity, and less vasoconstriction in response to stressors than males. Blood pressure changes are also influenced by levels of sex hormones; for example, estrogen may cause opposing vasodilation. Therefore, it is important to understand the differences in how males and females respond to low oxygen.

The main purpose of this study is to examine the differences between males and females in control of blood vessels during exposure to low oxygen. To study this question, we will test vasoreactivity to set physiological stressors in both males and females. Participants will be recruited at the Canadian sites, and we will test them while they breathe low oxygen for a short amount of time at low altitude. We will also perform assessments on the same participants during a two week stay at high altitude at White Mountain, CA, which is at an altitude of 3,800m. These data will have implications in the basic understanding of differences between male and female physiology. Specifically, to males and females living or travelling to high altitude.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between ages of 18-50
  • No medical history of cardiovascular, respiratory, nervous system, or metabolic disease
  • Females must be pre-menopausal

Exclusion criteria

  • Any known cardiovascular, respiratory, nervous system, or metabolic disease (however, participants with controlled arterial hypertension will not be excluded)
  • Having travelled above 2,000m within 1 month of testing at low and high altitude
  • Females who are pregnant, confirmed by a pregnancy test
  • Females who are post-menopausal
  • Participants that are classified as obese (body mass index > 30kg⋅m²)
  • Have a history of smoking regularly in the last 6 months (but nicotine substitutes (patch, gum) not an exclusion criteria)
  • Those with a known allergy to sulfites
  • Participants taking monoamine oxidase (MAO) inhibitors or tricyclic antidepressants

Treatment and study plan

Phenylephrine Hydrochloride

Drug

Series of three incremental bolus injections to observe α1-adrenoreceptor mediated vasoconstriction.

Other names: Neo-Synephrine

Cold pressor test

Other

Standardized sympathetic stressor involving submersion of the hand in ice-cold water for 3-minutes, aiming to elicit endogenous neurotransmitter release and blood pressure increases.

Isocapnic Acute Hypoxia

Other

During low altitude assessment, participants will be exposed to isocapnic hypoxia equivalent to 3,800m to assess responses to acute exposure.

Hyperoxia

Other

During high altitude assessments, participants will breathe an oxygen concentration comparable to their end-tidal values at low altitude for the assessment of the influences of acclimatization.

Primary outcomes

  1. Change in blood pressure

    Time frame: 18 minutes

    Phenylephrine sensitivity

  2. Change in arterial blood flow

    Time frame: 18 minutes

    Phenylephrine sensitivity

  3. Cold pressor test reactivity

    Time frame: 4 minutes

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 11, 2021
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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