Skip to main content
Clinical Trials/NCT03606434
NCT03606434CompletedNot Applicable

Sex Differences in Reflex Responses to Intermittent Hypoxia

University of Missouri-Columbia1 site in 1 country40 target enrollmentStarted: September 13, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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;
  • •history of alcoholism or substance abuse;
  • •hypertension.

Arms & Interventions

Hypoxic Exposure

Experimental

Men, and women in early or late follicular phase of menstrual cycle will be exposed to acute and intermittent hypoxic episodes.

Intervention: Hypoxic exposure (Other)

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jacqueline K Limberg, PhD

Assistant Professor

University of Missouri-Columbia

Study Sites (1)

Loading locations...

Similar Trials