Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation

NCT02332096 | Completed

• 1 other identifier: 2015P000038
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Obstructive Sleep Apnea; Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (1)

• Prevalence of sleep apnea in patients with atrial fibrillation

  Enrollment

Secondary Outcomes (5)

• Arrhythmia recurrence

  3 Months

• Arrhythmia recurrence

  6 Months

• Arrhythmia recurrence

  9 Months

• Need for antiarrhythmic medications

  3-12 Months

• CPAP compliance when prescribed

  3-12 Months

Study Arms (1)

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

Interventions

Home Sleep Testing Device DEVICE

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

Patients with Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea, Obstructive; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Patricia Tung, MD

  Beth Israel Deaconess Medical Center, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 6, 2015
• Study Start: June 1, 2015
• Primary Completion: February 7, 2020
• Study Completion: February 7, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)