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Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation

Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02332096
Enrollment
130
Registered
2015-01-06
Start date
2015-06-30
Completion date
2020-02-07
Last updated
2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Cardiac Arrhythmias, Obstructive Sleep Apnea

Brief summary

Diagnosis and treatment of sleep apnea with continuous positive airway pressure (CPAP) therapy has been shown to decrease arrhythmia recurrence in patients with AF following ablation. However, patients with AF undergoing ablation are not routinely screened for sleep apnea, despite an estimated sleep apnea prevalence of 25% in the general population, and perhaps higher among patients with AF. Home sleep testing is frequently used for evaluation of sleep apnea.

Detailed description

The American Academy of Sleep Medicine considers atrial fibrillation (AF) to be high risk for sleep disordered breathing, and recommends that those with AF be evaluated for sleep apnea in its clinical guidelines. However, this has not yet become standard practice. The primary reasons for this are that sleep apnea remains under-suspected and under-diagnosed by electrophysiology physicians treating patients with AF, overnight sleep studies are cumbersome and are frequently associated with patient discomfort and high cost, and a mechanism for coordinating sleep apnea screening and treatment referral has not been established in electrophysiology clinics. The gold standard for the diagnosis of sleep apnea is overnight polysomnography, typically conducted in a sleep laboratory, which can be costly and cumbersome for patients. Home sleep studies are FDA-approved for the diagnosis of sleep apnea and offer patients the opportunity to be assessed in a more natural sleep environment, and often in a more timely manner. It has been demonstrated that diagnosis and treatment of sleep apnea reduces the risk of arrhythmia recurrence following AF ablation to a level comparable to those without sleep apnea. The goal of this study is to examine the feasibility of screening all patients undergoing AF ablation for sleep apnea, and to refer those patients with sleep apnea for evaluation and treatment by a sleep specialist.

Interventions

DEVICEHome Sleep Testing Device

Patients will undergo obstructive sleep apnea screening with a FDA approved home sleep testing device.

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for the study include: 1. Patients age 18 years and older. 2. Patients with the diagnosis of atrial fibrillation presenting for clinical ablation procedure.

Exclusion criteria

for the study include: 1. Patients with an existing diagnosis of sleep apnea. 2. Patients who are unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
Prevalence of sleep apnea in patients with atrial fibrillationEnrollment

Secondary

MeasureTime frame
Arrhythmia recurrence3 Months
Need for antiarrhythmic medications3-12 Months
CPAP compliance when prescribed3-12 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026