RecruitingNot Applicable

Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study

United States60 participantsStarted 2021-07-12

Plain-language summary

The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk factor for atrial fibrosis development. The investigators aim to prove the presence of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF).

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Group A: 10 patients 18-75-year-old With mild OSA (5\<AHI\<15), confirmed by polysomnography. No previous AF diagnosis on the medical chart Group B: 10 patients 18-75-year-old With moderate OSA (15\<AHI\<30), confirmed by polysomnography. No previous AF diagnosis on the medical chart Group C: 10 patients 18-75-year-old With severe OSA (AHI\>30), confirmed by polysomnography. No previous AF diagnosis on the medical chart Group D (mild OSA+ AF): 10 patients 18-75-year-old With mild OSA (5\<AHI\<15), confirmed by polysomnography. Previous AF diagnosis * In this group, patients with AF and OSA who already have done MRI might be included. Group E (severe OSA +AF): 10 patients 18-75-year-old With severe OSA (AHI\>30), confirmed by polysomnography. Previous AF diagnosis \*In this group, patients with AF and OSA who already have done MRI might be included. Group F (Control): 10 Patients 18-75-year-old No previous OSA and/or AF Diagnosis on the medical chart Exclusion Criteria: * History of chronic heart failure (LVEF \< 50%), AF, myocardial infarction, valvular disease. * Prior cardiac or chest surgery. * Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea. * Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices/implants contraindicated for MRI, glomerular filtration rate \<30 ml/min, etc.). * Pregnancy. * Inabi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of atrial fibrosis in the left atrium measured by DE-MRI

Timeframe: Baseline visit

Trial details

NCT IDNCT04814420

SponsorTulane University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Christian Massad, MD

504-988-3072 cmassad@tulane.edu

View on ClinicalTrials.gov More Atrial Fibrillation trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.