Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study
Purpose
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.
Conditions
- Atrial Fibrillation
- Obstructive Sleep Apnea
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention 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).
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental group |
The group will include 15 patients with OSA 5 with mild OSA 5 with moderate OSA 5 with severe OSA |
|
|
Other Control group |
This group will include 5 patients with no OSA |
|
Recruiting Locations
New Orleans, Louisiana 70112
More Details
- Status
- Recruiting
- Sponsor
- Tulane University
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.