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OpenTrials
Completed

NCT Number: NCT02332096

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for the study include:

  • Patients age 18 years and older.
  • Patients with the diagnosis of atrial fibrillation presenting for clinical ablation procedure.

Exclusion criteria

for the study include:

  • Patients with an existing diagnosis of sleep apnea.
  • Patients who are unable to provide informed consent.

Treatment and study plan

Home Sleep Testing Device

Device

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

Primary outcomes

  1. Prevalence of sleep apnea in patients with atrial fibrillation

    Time frame: Enrollment

Secondary outcomes

  1. Arrhythmia recurrence

    Time frame: 3 Months

  2. Arrhythmia recurrence

    Time frame: 6 Months

  3. Arrhythmia recurrence

    Time frame: 9 Months

  4. Need for antiarrhythmic medications

    Time frame: 3-12 Months

  5. CPAP compliance when prescribed

    Time frame: 3-12 Months

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2015
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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