Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

  • STATUS
    Recruiting
  • days left to enroll
    22
  • participants needed
    20
  • sponsor
    Tulane University
Updated on 23 July 2021
heart disease
fibrillation

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 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.

Details
Condition Atrial Fibrillation (Pediatric), Dysrhythmia, obstructive sleep apnoea, Obstructive sleep apnea, obstructive sleep apnea syndrome, Arrhythmia, Atrial Fibrillation
Treatment Delayed enhancement magnetic resonance imaging (DE-MRI)
Clinical Study IdentifierNCT04814420
SponsorTulane University
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Experimental group: (15 patients)
-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
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