Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation

NCT ID: NCT02332096

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2020-02-07

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.

Conditions

Atrial Fibrillation; Obstructive Sleep Apnea; Cardiac Arrhythmias

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Atrial Fibrillation

We propose to enroll 100 patients with symptomatic paroxysmal or persistent AF without a known diagnosis of sleep apnea who are referred for an AF ablation procedure at BIDMC. All enrolled subjects will undergo pre-procedure screening sleep study using the Berlin questionnaire and home sleep study using an FDA approved home sleep testing device (HST).

Home Sleep Testing Device

Intervention Type: DEVICE

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

Interventions

Home Sleep Testing Device

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients age 18 years and older.

2. Patients with the diagnosis of atrial fibrillation presenting for clinical ablation procedure.

Exclusion Criteria

1. Patients with an existing diagnosis of sleep apnea.

2. Patients who are unable to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Patricia Tung

Instructor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Tung, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center, Harvard Medical School

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2015P000038

Identifier Type: -

Identifier Source: org_study_id