Hypoxia and Heart Rate Variability

University of Miami

Status: Begins enrollment in 3 months

Conditions: Pulmonary Disease, Chronic Obstructive; Hypoxia

Treatments: Other: Nocturnal Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT05606406

20220794

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Healthy Control Group

Active Comparator group

Description:

Individuals without lung disease will receive oxygen for a period of four hours

Treatment:

Other: Nocturnal Oxygen

Nocturnal hypoxemia group

Active Comparator group

Description:

Individuals with lung disease will receive oxygen for a period of four hours

Treatment:

Other: Nocturnal Oxygen