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Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02332096
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Patricia Tung, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Obstructive Sleep Apnea Cardiac Arrhythmias 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.

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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation
Study Start Date : June 2015
Actual Primary Completion Date : February 7, 2020
Actual Study Completion Date : February 7, 2020

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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.




Primary Outcome Measures :
  1. Prevalence of sleep apnea in patients with atrial fibrillation [ Time Frame: Enrollment ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332096


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Patricia Tung, MD Beth Israel Deaconess Medical Center, Harvard Medical School
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Responsible Party: Patricia Tung, Instructor in Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02332096    
Other Study ID Numbers: 2015P000038
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases