Trials / Unknown
UnknownNCT05155813
Prevalence of Sleep Apnea and Atrial Fibrillation
Prevalence of Sleep Apnea Among Consecutive Patients With Atrial Fibrillation.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WatchPAT | FDA-approved portable home sleep testing device worn on the wrist. |
Timeline
- Start date
- 2022-02-01
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2021-12-14
- Last updated
- 2022-06-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05155813. Inclusion in this directory is not an endorsement.