Sex Differences in Reflex Responses to Intermittent Hypoxia

NCT03606434 | Completed

• 2 other identifiers: 20113124R00HL130339
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia

  Hypoxia breathing will be recorded before and after intermittent hypoxia

  Through completion of intermittent hypoxia, an average of 3 hours

• Change from baseline Blood Pressure after intermittent hypoxia

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

  Through completion of intermittent hypoxia, an average of 3 hours

• Change from baseline Forearm Blood Flow after intermittent hypoxia

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

  Through completion of intermittent hypoxia, an average of 3 hours

Study Arms (1)

Hypoxic Exposure

EXPERIMENTAL

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

Other: Hypoxic exposure

Interventions

Hypoxic exposure OTHER

30 minutes of intermittent hypoxia

Hypoxic Exposure

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location

Study Officials

• Jacqueline Limberg, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will undergo same 30 minute intermittent hypoxia protocol.

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 30, 2018
• Study Start: September 13, 2018
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)