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Prevalence of Sleep Apnea and Atrial Fibrillation

Prevalence of Sleep Apnea Among Consecutive Patients With Atrial Fibrillation.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05155813
Enrollment
300
Registered
2021-12-14
Start date
2022-02-01
Completion date
2023-12-31
Last updated
2022-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Sleep Apnea

Keywords

sleep apnea, atrial fibrillation

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.

Interventions

DEVICEWatchPAT

FDA-approved portable home sleep testing device worn on the wrist.

Sponsors

Itamar-Medical, Israel
CollaboratorINDUSTRY
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of sleep apnea2 year studyPrevalence of sleep apnea among patients with atrial fibrillation

Secondary

MeasureTime frameDescription
Risk factors2 yearsWe will identify potential risk factors for AF in patients with sleep apnea using a logistic regression model
Time to diagnosis2 yearsWe will determine the efficiency and time-to-diagnosis of sleep apnea using a FDA approved home sleep testing device (i.e. WatchPAT)
Predictive value of typical screening tools2 yearsWe calculate the predictive value of traditional clinical screening tools in an AF population using the STOP-BANG questionnaire and Epworth Sleepiness Scale
Quality of life2 yearsWe will compare quality of life using the MAFSI in atrial fibrillation patients with and without sleep apnea.

Other

MeasureTime frameDescription
Autonomic index2 yearsCompare autonomic index in patients with AF who have sleep apnea versus those without sleep apnea
Insomnia Severity Index2 yearsAssess prevalence of insomnia among consecutive patients with atrial fibrillation

Countries

United States

Contacts

Primary ContactSogol Javaheri, MD
sjavaheri@bwh.harvard.edu617-983-7280
Backup ContactElliott Antman, MD
eantman@rics.bwh.harvard.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026