Prevalence of Sleep Apnea and Atrial Fibrillation

Prevalence of Sleep Apnea Among Consecutive Patients With Atrial Fibrillation.

The investigators will screen consecutive patients presenting to the atrial fibrillation clinic for sleep apnea using a FDA-approved home sleep testing device, WatchPAT to determine prevalence of sleep apnea in a clinic-based sample.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Sleep Apnea
• Intervention / Treatment: Device: WatchPAT

Detailed Description

The investigators will determine the prevalence of sleep apnea among consecutive patients with atrial fibrillation (AF) regardless of symptoms and determine the predictive value of screening tools for sleep apnea in this population. The primary outcome will be the prevalence of sleep apnea among all-comers with AF. Three secondary outcomes will be evaluated in the study. Investigators will determine the efficiency and time-to-diagnosis of sleep apnea using a FDA approved home sleep testing device (i.e. WatchPAT). These analyses will be compared to published studies performed using a traditional home sleep study test (which historically takes approximately 8-10 weeks). There will be no collection of data from a non-intervention group in our study. Second, investigtaors will calculate the predictive value of traditional clinical screening tools in an AF population using the STOP-BANG questionnaire and Epworth Sleepiness Scale. Third, investigators will identify potential risk factors for AF in patients with sleep apnea using a logistic regression model.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Sogol Javaheri, MD; Phone Number: 617-983-7280; Email: sjavaheri@bwh.harvard.edu
• Study Contact Backup: Name: Elliott Antman, MD; Email: eantman@rics.bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Sogol Javaheri, MD; Phone Number: 617-983-7288; Email: sjavaheri@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are referred to the Atrial Fibrillation Center of Excellence by their primary care provider or primary cardiologist will be screened by eligibility by study staff during their first clinic visit (in-person or virtually).

Description

Inclusion Criteria:

• Diagnosis of AF confirmed on any electrocardiographic recording
• Age greater than or equal to 18
• Ability to read and understand consent form, complete questionnaires, and provide informed consent

Exclusion Criteria:

• Prior diagnosis of sleep disordered breathing or negative testing within the past 2 years without significant change in weight or clinical symptoms of sleep apnea
• History of Raynaud

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of sleep apnea	Prevalence of sleep apnea among patients with atrial fibrillation	2 year study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to diagnosis	We will determine the efficiency and time-to-diagnosis of sleep apnea using a FDA approved home sleep testing device (i.e. WatchPAT)	2 years
Predictive value of typical screening tools	We calculate the predictive value of traditional clinical screening tools in an AF population using the STOP-BANG questionnaire and Epworth Sleepiness Scale	2 years
Quality of life	We will compare quality of life using the MAFSI in atrial fibrillation patients with and without sleep apnea.	2 years
Risk factors	We will identify potential risk factors for AF in patients with sleep apnea using a logistic regression model	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomic index	Compare autonomic index in patients with AF who have sleep apnea versus those without sleep apnea	2 years
Insomnia Severity Index	Assess prevalence of insomnia among consecutive patients with atrial fibrillation	2 years

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Itamar Medical LTD

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (ACTUAL): December 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: atrial fibrillation; sleep apnea
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Arrhythmias, Cardiac; Sleep Apnea Syndromes; Apnea; Atrial Fibrillation
• Other Study ID Numbers: 2021P002370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No