PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF

Overview

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.

Full Title of Study: “Prevalenza Delle Apnee Notturne e Riduzione Dei Fattori Promotori Nella Fibrillazione Atriale”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: December 31, 2022

Interventions

• Diagnostic Test: Polysomnography
  • Study of the sleep pattern
• Behavioral: Lifestyle counselling
  • Weight loss counselling

Clinical Trial Outcome Measures

Primary Measures

• Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation
  • Time Frame: 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
  • Time Frame: Baseline
  • Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation

Secondary Measures

• Change in body weight
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: Baseline and at 3, 6, 12, 24 and 36 months
  • Change in quality of life from baseline to 3 years

Participating in This Clinical Trial

Inclusion Criteria primary outcome:

• 1 episode of atrial fibrillation in the previous year Inclusion Criteria secondary outcome: – BMI > o = 27Kg/m2 – AHI >30 o con 15<AHI<30 associated with other symptoms (sleeplessness, uncontrolled hypertension and cerebral events) Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Investigator Details

• Lead Sponsor
  • Istituto Auxologico Italiano
• Provider of Information About this Clinical Study
  • Sponsor