Hypoxia and Heart Rate Variability

February 2, 2026 updated by: Trishul Siddharthan, University of Miami
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Trishul Siddharthan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Control Group
Individuals without lung disease will receive oxygen for a period of four hours
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.
Active Comparator: Nocturnal hypoxemia group
Individuals with lung disease will receive oxygen for a period of four hours
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Trishul Siddharthan, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220794

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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