Prevalence of Sleep Apnea and Atrial Fibrillation
Prevalence of Sleep Apnea Among Consecutive Patients With Atrial Fibrillation.
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 14, 2021
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 7, 2022
June 1, 2022
1.9 years
December 1, 2021
June 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of sleep apnea
Prevalence of sleep apnea among patients with atrial fibrillation
2 year study
Secondary Outcomes (4)
Time to diagnosis
2 years
Predictive value of typical screening tools
2 years
Quality of life
2 years
Risk factors
2 years
Other Outcomes (2)
Autonomic index
2 years
Insomnia Severity Index
2 years
Interventions
FDA-approved portable home sleep testing device worn on the wrist.
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Itamar-Medical, Israelcollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
PMID: 37019195DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 1, 2021
First Posted
December 14, 2021
Study Start
February 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
June 7, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share