Hypoxia and Heart Rate Variability

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Hypoxia and Heart Rate Variability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05606406
• Other study ID #: 20220794
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Trishul Siddharthan, MD
• Phone: 305-243-6388
• Email: tsiddhar[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypoxia
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Nocturnal 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QT Variability Index	Measured from electrocardiogram (ECG)	Up to 10 hours
Secondary	Normalized variance of the heart rate (HRVN)	Measured from ECG	Up to 10 hours
Secondary	QT-RR interval	Measured from ECG	Up to 10 hours