Image

Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

Recruiting
18-75 years
All
Phase N/A

Powered by AI

Overview

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

The investigators will also investigate the correlation between OSA metrics (nocturnal oxygen saturation and Apnea Hypopnea Index (AHI)) and degree of fibrosis at baseline and its progression.

Description

This is a prospective observational pilot study. Fifteen mild to severe OSA patients and five age- and Body Mass Index (BMI)-matched controls will undergo a DE-MRI. Demographics, medical history and polysomnography results will be collected. Patients diagnosed with obstructive sleep apnea have undergone a polysomnography before the study and were diagnosed based on this test. The investigators will not be performing a polysomnography for any of the patients, just collecting the previous results from their medical charts to confirm they have a true OSA diagnosis for their inclusion in the study.

Patients will be followed over a period of 6 months with a wearable device (WATCHPAT 300) that will record a home sleep apnea study biweekly, including OSA metrics like AHI and nocturnal oxygen variations. Patients will also use an ElectroCardioGram (ECG) Check device for arrhythmia detection.

Eligibility

Inclusion Criteria:

  • Experimental group: (15 patients)
    • 18-75-year-old, AND
    • With mild to severe OSA (mild: Apnea Hypopnea Index: AHI between 5-15, Moderate AHI= 15-30, severe AHI>30), diagnosed by polysomnography.
    • Patient with a creatinine measurement within the last 6 months.
  • Control group (5 patients): patients with no lung or heart disease, matched by age and

    BMI.

Exclusion Criteria:

  • History of chronic heart failure (Left Ventricle Ejection fraction (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.).
  • BMI > 35 kg/m2 (affects DE-MRI quality).
  • Pregnancy.
  • Contraindications to WATCHPAT device (peripheral neuropathy).
  • Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the use of WATCHPAT).
  • Inability to give informed consent.
  • No access to proper smartphone technology and/or internet.
  • Inability to return to follow up visit.

Study details
    Atrial Fibrillation
    Obstructive Sleep Apnea

NCT04814420

Tulane University

25 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.