Influence of Sleep Apnea on Risk of Atrial Fibrillation

Completed · Not applicable

Conditions studied: Sleep Apnea, Atrial Fibrillation

In brief

The Elucidation of the Influence of Sleep Apnea on Risk of Atrial Fibrillation study. The study involves a case control design to investigate the extent to which there is an independent relationship of sleep disordered breathing (SDB) and paroxysmal atrial fibrillation (PAF). Cases will be defined as clinically identified patients with PAF and controls as those without AF. In order to rigorously address important biologic confounding influences, the cases and controls will be individually matched based upon age, gender, race, and body mass index. Those participants with both PAF and SDB (Apnea Hypopnea Index, AHI\>=15) will be asked to return for a follow up exam after 3 months of SDB treatment in the Clinical Research Unit (CRU) for collection of the same measures collected at the baseline exam to observe for any significant changes with the purpose of collecting effect size data to inform future clinical trials. The total duration of the study is 4 years. The duration for any individual participant is up to from one to 13 weeks months, including a 3-month treatment period for those with moderate to severe SDB, i.e. AHI\>15.

Key facts

Study ID: NCT02576587
Run by: The Cleveland Clinic
People needed: 317
Starts: 2012-01-01
Expected to finish: 2017-02-22
Last updated by the study team: 2018-08-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Inclusion Criteria for Cases:
PAF defined by recurrent episodes of AF, which self-terminate within a 7-day period (based upon AHA consensus statement 77)
Age 18-80 years
Individuals able to participate in > 2 overnight/daytime sleep and physiologic assessments over a 3 month period.
Inclusion Criteria for Controls:
Age 18 to 80 years
Individuals in normal sinus rhythm (NSR) with no current AF or history of AF
Individuals able to participate in an overnight/daytime sleep and physiologic assessment.

You may not qualify if…

Exclusion Criteria for Cases:
PAF with rapid or uncontrolled rate (>120bpm)
Post-operative PAF
History of cardiac ablation or successful electro-cardioversion for PAF (ablation for other arrhythmias such as AVNRT and if PAF persists after cardioversion is acceptable )
Valvular stenosis, prosthesis or significant valvular insufficiency [i.e. those with moderate or greater severity of aortic stenosis (aortic valve area <1.5 cm2), mitral regurgitation which is moderate or more severe in degree (>20% regurgitant fraction) or moderate or greater severity mitral stenosis (mitral valve area <1.5 cm2)]
Atrial septal defect
Infiltrative/restrictive cardiomyopathy
Sick sinus syndrome
Previously diagnosed SDB on specific SDB treatments (CPAP, oral appliances)
Severe chronic insomnia
Circadian rhythm disorder (e.g. shift work sleep disorder, delayed or advanced sleep phase syndrome)
Insufficient sleep syndrome defined by reported sleep duration < 4 hrs
Supplemental oxygen use
Unstable medical conditions (e.g., new onset or changing angina, a myocardial infarction or congestive heart failure exacerbation documented within the previous 3 months, systolic heart failure (Left Ventricular Ejection Fraction < 35%), high grade cardiac dysrhythmia/heart block, stroke with functional limitations, uncontrolled hypertension (BP>170/110), abdominal aneurysm >5.5 cm or >1 cm growth/year, uncontrolled diabetes mellitus (HbA1c>9.0), pulmonary hypertension, non-skin cancer diagnosis or treatment within the previous year, end stage renal and hepatic failure, immunodeficiencies (HIV, HCV), uncontrolled hypo- or hyperthyroidism)
Psychiatric disorders which are inadequately treated
Compromised competence
Alcohol abuse (currently drinks >5 alcoholic drinks/day)
Pregnancy
Inability to provide informed consent
Illicit drug use over last 6 months
Rate controlling anti-arrhythmic medication (Classes I-III and V) with no further clinical occurrence of PAF
Has a Pacemaker or Implantable cardioverter-defibrillator.
Rationale for criteria: The goal of this study is to include those patients with PAF that is not secondary to the post-operative period or valvular disease and without ablation as these processes would result in alteration of atrial physiology and preclude assessment of independent SDB effects on AF which is independent of these conditions. Patients with sleep disorders will be excluded as sleep disorders may influence arrhythmogenesis. Those on treatment for SDB will be excluded because treatment would preclude assessment of SDB pathophysiologic effects on atrial arrhythmogenesis. Those with unstable medical conditions or rapid or uncontrolled heart rate will be excluded due to safety reasons.
Note: Exclusion criteria for positive airway pressure (PAP) intervention: Central Apnea Index>5 noted on baseline examination sleep study or evidence of Cheyne Stokes Respirations/periodic breathing (cyclical crescendo and decrescendo change in breathing amplitude).
Exclusion Criteria for Controls:

Where it is running

Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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