Clinical trial NCT03606434: Sex Differences in Reflex Responses to Intermittent Hypoxia
Official title: Sex Differences in Reflex Responses to Intermittent Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will undergo same 30 minute intermittent hypoxia protocol.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia
timeFrame: Through completion of intermittent hypoxia, an average of 3 hours
measure: Change from baseline Blood Pressure after intermittent hypoxia
timeFrame: Through completion of intermittent hypoxia, an average of 3 hours
measure: Change from baseline Forearm Blood Flow after intermittent hypoxia
timeFrame: Through completion of intermittent hypoxia, an average of 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jacqueline Limberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: