Prevalence of Sleep Apnea and Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Prevalence of Sleep Apnea Among Consecutive Patients With Atrial Fibrillation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155813
• Other study ID #: 2021P002370
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Brigham and Women's Hospital
• Contact: Sogol Javaheri, MD
• Phone: 617-983-7280
• Email: sjavaheri[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Atrial Fibrillation
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• WatchPAT
FDA-approved portable home sleep testing device worn on the wrist.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Itamar Medical LTD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Autonomic index	Compare autonomic index in patients with AF who have sleep apnea versus those without sleep apnea	2 years
Other	Insomnia Severity Index	Assess prevalence of insomnia among consecutive patients with atrial fibrillation	2 years
Primary	Prevalence of sleep apnea	Prevalence of sleep apnea among patients with atrial fibrillation	2 year study
Secondary	Time to diagnosis	We will determine the efficiency and time-to-diagnosis of sleep apnea using a FDA approved home sleep testing device (i.e. WatchPAT)	2 years
Secondary	Predictive value of typical screening tools	We calculate the predictive value of traditional clinical screening tools in an AF population using the STOP-BANG questionnaire and Epworth Sleepiness Scale	2 years
Secondary	Quality of life	We will compare quality of life using the MAFSI in atrial fibrillation patients with and without sleep apnea.	2 years
Secondary	Risk factors	We will identify potential risk factors for AF in patients with sleep apnea using a logistic regression model	2 years