Healthy ParticipantsNCT03606434
Sex Differences in Reflex Responses to Intermittent Hypoxia
A study testing Hypoxic exposure in people with Healthy Participants, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of the present study is to determine whether there are sex differences in the reflex responses to hypoxia in humans. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Hypoxic exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2018to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 9Show fewer
- smoking;
- history of alcoholism or substance abuse;
- hypertension.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65211
About this study
The purpose of the present study is to determine whether there are sex differences in the reflex responses to hypoxia in humans.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Hypoxic exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxic exposureOther
30 minutes of intermittent hypoxia
| Study group | Role | What they receive |
|---|---|---|
| Hypoxic Exposure | Experimental | Men, and women in early or late follicular phase of menstrual cycle will be exposed to acute and intermittent hypoxic episodes. Receives: Other: Hypoxic exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia
Hypoxia breathing will be recorded before and after intermittent hypoxia
Measured: 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
Measured: 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
Measured: Through completion of intermittent hypoxia, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start13 Sep 2018
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo same 30 minute intermittent hypoxia protocol.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jacqueline K Limberg, PhD, University of Missouri-Columbia
- Investigators
- Jacqueline Limberg, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606434
- Sponsor's protocol ID
- 2011312
- Other IDs
- 4R00HL130339
- Status last verified
- Jul 2021
- First submitted
- 11 Jun 2018
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Reflex Responses to Intermittent Hypoxia
- ClinicalTrials.gov ID
- NCT03606434
- Acronym / sponsor ID
- 2011312
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo same 30 minute intermittent hypoxia protocol.
| Arm | Type | Receives |
|---|---|---|
| Hypoxic Exposure | Experimental | Other: Hypoxic exposureMen, and women in early or late follicular phase of menstrual cycle will be exposed to acute and intermittent hypoxic episodes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- healthy adult men and women;
- BMI <30 kg/m2;
- non-pregnant;
- non-breastfeeding;
- non-smokers;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxic exposure30 minutes of intermittent hypoxia | Other | Hypoxic Exposure |
Primary outcome
Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia
Time frame: Through completion of intermittent hypoxia, an average of 3 hours
Hypoxia breathing will be recorded before and after intermittent hypoxia
Change from baseline Blood Pressure after intermittent hypoxia
Time frame: Through completion of intermittent hypoxia, an average of 3 hours
Systolic and diastolic blood pressure will be recorded before and after intermittent hypoxia
Change from baseline Forearm Blood Flow after intermittent hypoxia
Time frame: Through completion of intermittent hypoxia, an average of 3 hours
Blood flow in the forearm will be recorded before and after intermittent hypoxia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Limberg, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxic exposure in people with Healthy Participants, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Hypoxic Ventilatory Response after intermittent hypoxia (time frame: Through completion of intermittent hypoxia, an average of 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.