Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

Conditions
-----------------
Atrial Fibrillation, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Delayed enhancement magnetic resonance imaging (DE-MRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Twenty participants would be an adequate sample size for this pilot study to represent all stages of OSA and controls (5 mild, 5 moderate, 5 severe OSA, and 5 controls with no OSA).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>The group will include 15 patients with OSA 5 with mild OSA 5 with moderate OSA 5 with severe OSA | Device: Delayed enhancement magnetic resonance imaging (DE-MRI)<br>* The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.<br>|
| Other: Control group<br>This group will include 5 patients with no OSA | Device: Delayed enhancement magnetic resonance imaging (DE-MRI)<br>* The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of atrial fibrosis measured by DE-MRI | The percent change will be measured via DE-MRI. The purpose of DE-MRI is to quantify the degree of atrial structural remodeling or fibrosis. | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of arrhythmia | The patients will use ECG check device to detect the arrhythmia occurrence. | From baseline to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardioversion, Ablation, Atrial Fibrosis, Delayed Enhancement Magnetic Resonance Imaging, Electrocardiogram, Nocturnal oxygen saturation, Apnea Hypopnea Index