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Hypoxia and Heart Rate Variability

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Hypoxia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nocturnal Oxygen
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Healthy Control Group

Nocturnal hypoxemia group

Arm Description

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

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

Outcomes

Primary Outcome Measures

QT Variability Index
Measured from electrocardiogram (ECG)

Secondary Outcome Measures

Normalized variance of the heart rate (HRVN)
Measured from ECG
QT-RR interval
Measured from ECG

Full Information

First Posted
November 1, 2022
Last Updated
August 14, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05606406
Brief Title
Hypoxia and Heart Rate Variability
Official Title
Hypoxia and Heart Rate Variability
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Hypoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Control Group
Arm Type
Active Comparator
Arm Description
Individuals without lung disease will receive oxygen for a period of four hours
Arm Title
Nocturnal hypoxemia group
Arm Type
Active Comparator
Arm Description
Individuals with lung disease will receive oxygen for a period of four hours
Intervention Type
Other
Intervention Name(s)
Nocturnal Oxygen
Intervention Description
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 Outcome Measure Information:
Title
QT Variability Index
Description
Measured from electrocardiogram (ECG)
Time Frame
Up to 10 hours
Secondary Outcome Measure Information:
Title
Normalized variance of the heart rate (HRVN)
Description
Measured from ECG
Time Frame
Up to 10 hours
Title
QT-RR interval
Description
Measured from ECG
Time Frame
Up to 10 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trishul Siddharthan, MD
Phone
305-243-6388
Email
tsiddhar@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trishul Siddharthan, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trishul Siddharthan, MD
Phone
305-243-6388
Email
tsiddhar@miami.edu
First Name & Middle Initial & Last Name & Degree
Trishul Siddharthan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypoxia and Heart Rate Variability

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