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DE-MRI for Sleep Apnea-Related Heart Changes

N/A

Recruiting

Led By Uzodinma Emerenini, MD

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Experimental group: 18-75-year-old with mild to severe OSA diagnosed by polysomnography

Control group: Patients with no lung or heart disease, matched by age and BMI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months

Awards & highlights

Study Summary

This trialis researching if sleep apnea can cause changes to the heart and how those changes are related to oxygen levels and the severity of sleep apnea.

Who is the study for?

This study is for adults aged 18-75 with mild to severe Obstructive Sleep Apnea (OSA) diagnosed by sleep studies, who have normal kidney function. It excludes those with serious heart conditions, other advanced lung diseases, contraindications to MRI scans like allergies or certain implants, pregnant women, and individuals unable to consent or follow up.Check my eligibility

What is being tested?

The trial aims to detect atrial fibrosis progression in OSA patients using Delayed Enhancement Magnetic Resonance Imaging (DE-MRI). It will also explore the relationship between OSA severity and fibrosis. Participants are divided into two groups: one with OSA and another healthy control group matched by age and BMI.See study design

What are the potential side effects?

There may be minimal side effects related to DE-MRI such as discomfort from lying still during the scan or a rare allergic reaction to the contrast dye used in imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old and have been diagnosed with OSA through a sleep study.

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I have no lung or heart disease and match the age and BMI criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change of atrial fibrosis measured by DE-MRI

Secondary outcome measures

The occurrence of arrhythmia

Trial Design

2Treatment groups

Experimental Treatment

Group I: Experimental groupExperimental Treatment1 Intervention

The group will include 15 patients with OSA 5 with mild OSA 5 with moderate OSA 5 with severe OSA

Group II: Control groupExperimental Treatment1 Intervention

This group will include 5 patients with no OSA

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor

115 Previous Clinical Trials

226,482 Total Patients Enrolled

5 Trials studying Atrial Fibrillation

1,062 Patients Enrolled for Atrial Fibrillation

Uzodinma Emerenini, MDPrincipal InvestigatorTulane University Medical Center

Nassir Marrouche, MDStudy DirectorTulane University Medical Center

6 Previous Clinical Trials

1,048 Total Patients Enrolled

4 Trials studying Atrial Fibrillation

648 Patients Enrolled for Atrial Fibrillation

Media Library

Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) Clinical Trial Eligibility Overview. Trial Name: NCT04814420 — N/A

Atrial Fibrillation Research Study Groups: Experimental group, Control group

Atrial Fibrillation Clinical Trial 2023: Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) Highlights & Side Effects. Trial Name: NCT04814420 — N/A

Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04814420 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my involvement permissible in this trial?

"This clinical trial seeks 20 participants with obstructive sleep apnea, aged 18-75. To qualify, they must have a mild (AHI 5-15), moderate (AHI 15-30) or severe (AHI>30) form of OSA as diagnosed by polysomnography. The experimental group consists of 15 patients and the control group is made up of 5 individuals who do not possess any heart or lung diseases that match both age and BMI."

Answered by AI

Are there any age limitations on participants of this experiment?

"Patients interested in this medical investigation must be at least eighteen and no more than seventy-five years of age."

Answered by AI

Are recruitment efforts for this experiment ongoing?

"Affirmative. Data available on clinicaltrials.gov reveals that this medical trial is presently recruiting participants. The study was initially posted to the database on July 12th 2021 and has been updated most recently on November 21st 2022, with capacity for 20 patients at a single site."

Answered by AI

What is the aggregate patient population involved in this medical trial?

"Affirmative, the information on clinicaltrials.gov reveals that this research endeavour is actively recruiting members. This trial was originally posted on July 12th 2021 and last updated November 21st 2022; 20 participants are currently sought from one site."

Answered by AI