Hypoxia and Heart Rate Variability

Sponsor
University of Miami (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05606406
Collaborator
(none)
70
1
2
12
5.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nocturnal Oxygen
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hypoxia and Heart Rate Variability
Anticipated Study Start Date :
Apr 30, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. QT Variability Index [Up to 10 hours]

    Measured from electrocardiogram (ECG)

Secondary Outcome Measures

  1. Normalized variance of the heart rate (HRVN) [Up to 10 hours]

    Measured from ECG

  2. QT-RR interval [Up to 10 hours]

    Measured from ECG

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami Miami Florida United States 33136

Sponsors and Collaborators

  • University of Miami

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Trishul Siddharthan, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier:
NCT05606406
Other Study ID Numbers:
  • 20220794
First Posted:
Nov 4, 2022
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2023