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NCT Number: NCT05606406

Hypoxia and Heart Rate Variability

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Hypoxia Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location contact

Trishul Siddharthan, MD

CONTACT

[email protected]

305-243-6388

Trishul Siddharthan, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nocturnal Oxygen

Other

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.

Primary outcomes

  1. QT Variability Index

    Time frame: Up to 10 hours

    Measured from electrocardiogram (ECG)

Secondary outcomes

  1. Normalized variance of the heart rate (HRVN)

    Time frame: Up to 10 hours

    Measured from ECG

  2. QT-RR interval

    Time frame: Up to 10 hours

    Measured from ECG

Study contacts

Contact information is provided by the study sponsor or research team.

Trishul Siddharthan, MD

CONTACT

[email protected]

305-243-6388

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2022
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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