Prevalence of Sleep Apnea and Atrial Fibrillation

NCT ID: NCT05155813

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-12-31

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.

Conditions

Sleep Apnea; Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

WatchPAT

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Itamar-Medical, Israel

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sogol Javaheri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sogol Javaheri, MD

Role: CONTACT

sjavaheri@bwh.harvard.edu

617-983-7280

Elliott Antman, MD

Role: CONTACT

eantman@rics.bwh.harvard.edu

Facility Contacts

Sogol Javaheri, MD

Role: primary

sjavaheri@partners.org

617-983-7288

References

Mills EW, Cassidy M, Sofer T, Tadros T, Zei P, Sauer W, Romero J, Martin D, Antman EM, Javaheri S. Evaluation of obstructive sleep apnea among consecutive patients with all patterns of atrial fibrillation using WatchPAT home sleep testing. Am Heart J. 2023 Jul;261:95-103. doi: 10.1016/j.ahj.2023.03.014. Epub 2023 Apr 3.

Reference Type: DERIVED

PMID: 37019195 (View on PubMed)

Other Identifiers

2021P002370

Identifier Type: -

Identifier Source: org_study_id