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Nocturnal Oxygen for Hypoxia

N/A
Waitlist Available
Led By Trishul Siddharthan, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic respiratory condition resting Sat < 95% off oxygen
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 hours
Awards & highlights

Summary

This trial looks at how changes in oxygen levels affect the heart's electrical activity in people with and without oxygen needs.

Who is the study for?
This trial is for individuals who can consent and have a chronic respiratory condition with oxygen saturation below 95% when not using supplemental oxygen. It's not for those with severe obesity, recent heart issues, uncontrolled medical conditions like angina or high blood pressure, cancer, or active major depression.
What is being tested?
The study is looking at how varying oxygen levels during the night affect heart electrical activity in people with chronic lung problems who do and don't use nighttime oxygen.
What are the potential side effects?
While the trial involves nocturnal oxygen therapy which typically has minimal side effects, potential risks may include dry or bloody nose, morning headaches, and discomfort from wearing the mask.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My oxygen levels fall below 95% when I'm not using supplemental oxygen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of heart attack, heart surgery, heart failure, or stroke.
Select...
I do not have uncontrolled heart issues, high blood pressure, cancer, or severe mental health conditions.
Select...
My BMI is over 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
QT Variability Index
Secondary study objectives
Heart rate
QT-RR interval

Trial Design

2Treatment groups
Active Control
Group I: Nocturnal hypoxemia groupActive Control1 Intervention
Individuals with lung disease will receive oxygen for a period of four hours
Group II: Healthy Control GroupActive Control1 Intervention
Individuals without lung disease will receive oxygen for a period of four hours

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
935 Previous Clinical Trials
422,147 Total Patients Enrolled
4 Trials studying Hypoxia
566 Patients Enrolled for Hypoxia
Trishul Siddharthan, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Nocturnal hypoxemia group Clinical Trial Eligibility Overview. Trial Name: NCT05606406 — N/A
Hypoxia Research Study Groups: Nocturnal hypoxemia group, Healthy Control Group
Hypoxia Clinical Trial 2023: Nocturnal hypoxemia group Highlights & Side Effects. Trial Name: NCT05606406 — N/A
Nocturnal hypoxemia group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05606406 — N/A
~47 spots leftby Dec 2025
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