Hypoxia and Heart Rate Variability
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Miami
About this trial
The purpose of this study is to evaluate how variations in oxygen demands may change heart electrical activity in individuals with and without oxygen dependence.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
BMI > 40 kg/m2
Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, cancer, and active psychiatric disease (e.g., major depression)
Ability to provide consent
Trial design
Design model
Parallel
Treatments tested in this trial
Nocturnal Oxygen
Other interventionNocturnal oxygen will be increased hourly for a period of four hours up to 4 liters per minute (LPM). If the oxygen saturation (SpO2) falls below 70% the oxygen rate will be increased until patients achieve the threshold of 70% and then will proceed with titrations of 1 liter per minute LPM per hour.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Healthy Control GroupActive comparator 1 intervention
Group B: Nocturnal hypoxemia groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
QT Variability Index
Measured from electrocardiogram (ECG)
Time frame
Up to 10 hoursSecondary outcomes
1
Normalized variance of the heart rate (HRVN)
Measured from ECG
Time frame
Up to 10 hours2
QT-RR interval
Measured from ECG
Time frame
Up to 10 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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