Clinical trial NCT02332096: Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation
Official title: Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Obstructive Sleep Apnea
Cardiac Arrhythmias
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of sleep apnea in patients with atrial fibrillation
timeFrame: Enrollment
Secondary outcomes:
measure: Arrhythmia recurrence
timeFrame: 3 Months
measure: Arrhythmia recurrence
timeFrame: 6 Months
measure: Arrhythmia recurrence
timeFrame: 9 Months
measure: Need for antiarrhythmic medications
timeFrame: 3-12 Months
measure: CPAP compliance when prescribed
timeFrame: 3-12 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center, Harvard Medical School
name: Patricia Tung, MD
role: PRINCIPAL_INVESTIGATOR
References: