Sex Differences in Reflex Responses to Intermittent Hypoxia

• Sponsor: University of Missouri-Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03606434
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 34
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Other: Hypoxic exposure	N/A

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
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants will undergo same 30 minute intermittent hypoxia protocol.All participants will undergo same 30 minute intermittent hypoxia protocol.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Sex Differences in Reflex Responses to Intermittent Hypoxia
• Actual Study Start Date: Sep 13, 2018
• Actual Primary Completion Date: Jul 15, 2021
• Actual Study Completion Date: Jul 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypoxic Exposure Men, and women in early or late follicular phase of menstrual cycle will be exposed to acute and intermittent hypoxic episodes.	Other: Hypoxic exposure; 30 minutes of intermittent hypoxia

Outcome Measures

Primary Outcome Measures

1. Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia [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 [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 [Through completion of intermittent hypoxia, an average of 3 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: 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;

• smoking;

• history of alcoholism or substance abuse;

• hypertension.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri-Columbia	Columbia	Missouri	United States	65211

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jacqueline Limberg, PhD, University of Missouri-Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jacqueline K Limberg, PhD, Assistant Professor, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT03606434
• Other Study ID Numbers: 2011312; 4R00HL130339
• First Posted: Jul 30, 2018
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypoxia

Study Results

No Results Posted as of Jul 21, 2021