PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF

Active, not recruiting

• Conditions: Osa Syndrome; Atrial Fibrillation

• Registration Number: NCT05784077
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

This study aims to identify how many patients who have atrial fibrillation, also have sleep apnoea. This is important because sleep apnoea can be a trigger to atrial fibrillation and it can be corrected with a simple intervention. Therefore it is important to understand its prevalence (how many patients with atrial fibrillation are affected by it). Also, obesity and sleep disorders are often associated, therefore the evolution of atrial fibrillation is studied in patients who also have obesity and have lost weight compared with patients who did not loose any weight or are not obese. As medications or therapy are not changed, this is an observational study.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-12-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-24
• Last Update Posted: 2023-03-24
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 343

Inclusion Criteria

Not provided

Exclusion Criteria

• Ejection Fraction <50%
• HFpEF not related to atrial fibrillation.
• coronary artery disease
• valvular cardiomyopathy
• patient already in treatment for sleep apnoea
• hyperthyroidism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation	Baseline and at 3, 6, 12, 24 and 36 months	Change in prevalence of obstructive sleep apnoea from baseline to 3 years
Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation	Baseline	Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
Change in body weight	Baseline and at 3, 6, 12, 24 and 36 months	Change in body weight from baseline to 3 years
Change in incidence of atrial fibrillation recurrencies	Baseline and at 3, 6, 12, 24 and 36 months	Change in incidence of atrial fibrillation recurrencies from baseline to 3 years
Change in quality of life	Baseline and at 3, 6, 12, 24 and 36 months	Change in quality of life from baseline to 3 years

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Milan, Italy