Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:

Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332096
• Other study ID #: 2015P000038
• Status: Completed
• Start date: June 2015
• Est. completion date: February 7, 2020

Study information

• Verified date: August 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmias
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Home Sleep Testing Device
Patients will undergo obstructive sleep apnea screening with a FDA approved home sleep testing device.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of sleep apnea in patients with atrial fibrillation		Enrollment
Secondary	Arrhythmia recurrence		3 Months
Secondary	Arrhythmia recurrence		6 Months
Secondary	Arrhythmia recurrence		9 Months
Secondary	Need for antiarrhythmic medications		3-12 Months
Secondary	CPAP compliance when prescribed		3-12 Months