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Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study

Tulane University · NCT04814420

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
3
Study start
July 12, 2021
Record last updated
June 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Delayed enhancement magnetic resonance imaging (DE-MRI)

Conditions: Atrial Fibrillation; Obstructive Sleep Apnea

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.
  • Inability to give informed consent.

Recruiting US locations

  • East Jefferson General Hospital

    New Orleans, LA 70006

    Site contact: Christian Massad, MD · 504-988-3072 · cmassad@tulane.edu

  • University Medical Center

    New Orleans, LA 70112

    Site contact: Christian Massad, MD · 504-988-3072 · cmassad@tulane.edu

  • Tulane Doctors - Speciality Care - Napoleon

    New Orleans, LA 70115

    Site contact: Christian Massad, MD · 504-988-3072 · cmassad@tulane.edu

Study contacts (from the official record)

  • Christian Massad, MD · 504-988-3072 · cmassad@tulane.edu
  • Kunal Sameer, MD, MHA · 504-988-3072 · ksameer@tulane.edu
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Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study (NCT04814420) | Bored Studies