Hypoxia and Heart Rate Variability

Not Applicable

Not yet recruiting

• Conditions: Hypoxia; Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Nocturnal Oxygen

• Registration Number: NCT05606406
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-01
• Study First Posted: 2022-11-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23
• Study Start: 2025-12-30
• Primary Completion: 2027-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nocturnal hypoxemia group	Nocturnal Oxygen	Individuals with lung disease will receive oxygen for a period of four hours
Healthy Control Group	Nocturnal Oxygen	Individuals without lung disease will receive oxygen for a period of four hours

Primary Outcome Measures

Name	Time	Method
QT Variability Index	Up to 10 hours	Measured from electrocardiogram (ECG)

Secondary Outcome Measures

Name	Time	Method
Normalized variance of the heart rate (HRVN)	Up to 10 hours	Measured from ECG
QT-RR interval	Up to 10 hours	Measured from ECG

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States