Hypoxia and Heart Rate Variability

NCT05606406 | Not Yet Recruiting

• 1 other identifier: 20220794
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Hypoxia

Outcome Measures

Primary Outcomes (1)

• QT Variability Index

  Measured from electrocardiogram (ECG)

  Up to 10 hours

Secondary Outcomes (2)

• Normalized variance of the heart rate (HRVN)

  Up to 10 hours

• QT-RR interval

  Up to 10 hours

Study Arms (2)

Healthy Control Group

ACTIVE COMPARATOR

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

Other: Nocturnal Oxygen

Nocturnal hypoxemia group

ACTIVE COMPARATOR

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

Other: Nocturnal Oxygen

Interventions

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.

Healthy Control Group; Nocturnal hypoxemia group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide consent

You may not qualify if:

• 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
• Ability to provide consent
• Chronic respiratory condition resting Sat \< 95% off oxygen
• 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)

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• Trishul Siddharthan, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trishul Siddharthan, MD

CONTACT

305-243-6388; tsiddhar@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 4, 2022
• Study Start: May 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)