Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Obstructive Sleep Apnea; Cardiac Arrhythmias
• Intervention / Treatment: Device: Home Sleep Testing Device

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.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Device: Home Sleep Testing Device; Patients will undergo obstructive sleep apnea screening with a FDA approved home sleep testing device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of sleep apnea in patients with atrial fibrillation	Enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Arrhythmia recurrence	3 Months
Arrhythmia recurrence	6 Months
Arrhythmia recurrence	9 Months
Need for antiarrhythmic medications	3-12 Months
CPAP compliance when prescribed	3-12 Months

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Patricia Tung, MD, Beth Israel Deaconess Medical Center, Harvard Medical School

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: January 5, 2015
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 2015P000038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO