Hypoxia and Heart Rate Variability

Study Overview
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Brief Summary
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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.

Official Title
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Hypoxia and Heart Rate Variability

Conditions
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Pulmonary Disease, Chronic Obstructive, Hypoxia

Intervention / Treatment
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* Other: Nocturnal Oxygen


Participation Criteria
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Eligibility Criteria
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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 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, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Control Group<br>Individuals without lung disease will receive oxygen for a period of four hours | Other: Nocturnal Oxygen<br>* 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.<br>|
| Active Comparator: Nocturnal hypoxemia group<br>Individuals with lung disease will receive oxygen for a period of four hours | Other: Nocturnal Oxygen<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT Variability Index | Measured from electrocardiogram (ECG) | Up to 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalized variance of the heart rate (HRVN) | Measured from ECG | Up to 10 hours | 
| QT-RR interval | Measured from ECG | Up to 10 hours |