Sex Differences in Reflex Responses to Intermittent Hypoxia
Primary Purpose
Healthy Participants
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypoxic exposure
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Participants
Eligibility Criteria
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.
Sites / Locations
- University of Missouri-Columbia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypoxic Exposure
Arm Description
Men, and women in early or late follicular phase of menstrual cycle will be exposed to acute and intermittent hypoxic episodes.
Outcomes
Primary Outcome Measures
Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia
Hypoxia breathing will be recorded before and after intermittent hypoxia
Change from baseline Blood Pressure after intermittent hypoxia
Systolic and diastolic blood pressure will be recorded before and after intermittent hypoxia
Change from baseline Forearm Blood Flow after intermittent hypoxia
Blood flow in the forearm will be recorded before and after intermittent hypoxia
Secondary Outcome Measures
Full Information
NCT ID
NCT03606434
First Posted
June 11, 2018
Last Updated
July 19, 2021
Sponsor
University of Missouri-Columbia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03606434
Brief Title
Sex Differences in Reflex Responses to Intermittent Hypoxia
Official Title
Sex Differences in Reflex Responses to Intermittent Hypoxia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will undergo same 30 minute intermittent hypoxia protocol.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypoxic Exposure
Arm Type
Experimental
Arm Description
Men, and women in early or late follicular phase of menstrual cycle will be exposed to acute and intermittent hypoxic episodes.
Intervention Type
Other
Intervention Name(s)
Hypoxic exposure
Intervention Description
30 minutes of intermittent hypoxia
Primary Outcome Measure Information:
Title
Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia
Description
Hypoxia breathing will be recorded before and after intermittent hypoxia
Time Frame
Through completion of intermittent hypoxia, an average of 3 hours
Title
Change from baseline Blood Pressure after intermittent hypoxia
Description
Systolic and diastolic blood pressure will be recorded before and after intermittent hypoxia
Time Frame
Through completion of intermittent hypoxia, an average of 3 hours
Title
Change from baseline Forearm Blood Flow after intermittent hypoxia
Description
Blood flow in the forearm will be recorded before and after intermittent hypoxia
Time Frame
Through completion of intermittent hypoxia, an average of 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Limberg, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sex Differences in Reflex Responses to Intermittent Hypoxia
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