Prevalence of Sleep Apnea and Atrial Fibrillation

• Conditions: Atrial Fibrillation; Sleep Apnea

• Registration Number: NCT05155813
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-14
• Study Start: 2022-02-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-07
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of sleep apnea	2 year study	Prevalence of sleep apnea among patients with atrial fibrillation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States