Sex Differences in Reflex Responses to Intermittent Hypoxia

NCT ID: NCT03606434

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-13

Study Completion Date

2021-07-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will undergo same 30 minute intermittent hypoxia protocol.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Hypoxic Exposure

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

Group Type EXPERIMENTAL

Hypoxic exposure

Intervention Type OTHER

30 minutes of intermittent hypoxia

Interventions

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Hypoxic exposure

30 minutes of intermittent hypoxia

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jacqueline K Limberg, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacqueline Limberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri-Columbia

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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4R00HL130339

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011312

Identifier Type: -

Identifier Source: org_study_id

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