Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation
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|ClinicalTrials.gov Identifier: NCT02332096|
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : August 5, 2020
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|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Obstructive Sleep Apnea Cardiac Arrhythmias||Device: Home Sleep Testing Device|
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|
|Actual Enrollment :||130 participants|
|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|
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.
- Prevalence of sleep apnea in patients with atrial fibrillation [ Time Frame: Enrollment ]
- Arrhythmia recurrence [ Time Frame: 3 Months ]
- Arrhythmia recurrence [ Time Frame: 6 Months ]
- Arrhythmia recurrence [ Time Frame: 9 Months ]
- Need for antiarrhythmic medications [ Time Frame: 3-12 Months ]
- 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|
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.
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
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Patricia Tung, MD||Beth Israel Deaconess Medical Center, Harvard Medical School|
|Responsible Party:||Patricia Tung, Instructor in Medicine, Beth Israel Deaconess Medical Center|
|Other Study ID Numbers:||
|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|
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases