Clinical trial NCT05155813: Prevalence of Sleep Apnea and Atrial Fibrillation
Official title: Prevalence of Sleep Apnea Among Consecutive Patients With Atrial Fibrillation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Atrial Fibrillation
Keywords: sleep apnea
atrial fibrillation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Itamar-Medical, Israel
First posted: 2021-12-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of sleep apnea
timeFrame: 2 year study
Secondary outcomes:
measure: Time to diagnosis
timeFrame: 2 years
measure: Predictive value of typical screening tools
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
measure: Risk factors
timeFrame: 2 years
Other outcomes:
measure: Autonomic index
timeFrame: 2 years
measure: Insomnia Severity Index
timeFrame: 2 years
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: