Hypoxia, Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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.
Interventions
OTHERNocturnal Oxygen
Nocturnal 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.
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Participants Inclusion Criteria: • Ability to provide consent
Exclusion criteria
* 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) Nocturnal Hypoxemia Inclusion Criteria: * Ability to provide consent * Chronic respiratory condition resting Sat \< 95% off oxygen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QT Variability Index | Up to 10 hours | Measured from electrocardiogram (ECG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normalized variance of the heart rate (HRVN) | Up to 10 hours | Measured from ECG |
| QT-RR interval | Up to 10 hours | Measured from ECG |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTrishul Siddharthan, MD
University of Miami
Outcome results
None listed