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Completed

NCT Number: NCT03606434

Sex Differences in Reflex Responses to Intermittent Hypoxia

The purpose of the present study is to determine whether there are sex differences in the reflex responses to hypoxia in humans.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

About this study

Over 35% of the US population will develop sleep apnea at some point in their life. Sleep apnea is the most common form of sleep disordered breathing and patients with sleep apnea are at increased risk of developing high blood pressure. Intermittent, repeated exposures to low oxygen during sleep (intermittent hypoxia, IH) has been implicated as the primary stimulus for increases in sympathetic nervous system activity and blood pressure with sleep apnea. Interestingly there are some reports of a lower incidence of hypertension in women with sleep apnea when compared to men. Results from the present study will provide information important to the investigator's understanding of potential sex-differences in clinical outcomes for conditions related to acute/chronic hypoxia and may have important implications for treatments which may improve blood pressure control in patients with sleep apnea.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy adult men and women;
  • BMI <30 kg/m2;
  • non-pregnant;
  • non-breastfeeding;
  • non-smokers;
  • premenopausal women with a normal menstrual cycle unaffected by hormonal contraceptive use;
  • taking no medications known to affect autonomic or cardiovascular function (PI discretion).

Exclusion criteria

  • taking any medications known to affect the cardiovascular or autonomic nervous system (e.g. alpha-blockers, beta-blockers, etc);
  • a self-reported history of hepatic, renal, pulmonary, cardiovascular, or neurological diseases;
  • stroke or neurovascular disease;
  • bleeding/clotting disorder;
  • sleep apnea or other sleep disorders;
  • diabetes;
  • smoking;
  • history of alcoholism or substance abuse;
  • hypertension.

Treatment and study plan

Hypoxic exposure

Other

30 minutes of intermittent hypoxia

Primary outcomes

  1. Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia

    Time frame: Through completion of intermittent hypoxia, an average of 3 hours

    Hypoxia breathing will be recorded before and after intermittent hypoxia

  2. Change from baseline Blood Pressure after intermittent hypoxia

    Time frame: Through completion of intermittent hypoxia, an average of 3 hours

    Systolic and diastolic blood pressure will be recorded before and after intermittent hypoxia

  3. Change from baseline Forearm Blood Flow after intermittent hypoxia

    Time frame: Through completion of intermittent hypoxia, an average of 3 hours

    Blood flow in the forearm will be recorded before and after intermittent hypoxia

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2018
Registry last updated
Jul 21, 2021

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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