PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF

NCT05784077 | Unknown

• 1 other identifier: 09C020
• Study Type: observational
• Target: 343
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Osa Syndrome

Outcome Measures

Primary Outcomes (2)

• Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation

  Change in prevalence of obstructive sleep apnoea from baseline to 3 years

  Baseline and at 3, 6, 12, 24 and 36 months

• Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation

  Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation

  Baseline

Secondary Outcomes (3)

• Change in body weight

  Baseline and at 3, 6, 12, 24 and 36 months

• Change in incidence of atrial fibrillation recurrencies

  Baseline and at 3, 6, 12, 24 and 36 months

• Change in quality of life

  Baseline and at 3, 6, 12, 24 and 36 months

Interventions

Polysomnography DIAGNOSTIC_TEST

Study of the sleep pattern

Lifestyle counselling BEHAVIORAL

Weight loss counselling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients between 18 and 75 years of age, male and female, who come to the study centre between January 2019 and January 2023 with a diagnosis of atrial fibrillation and a recurrence (or first episode) in the previous year and who can undergo polysomnography

You may qualify if:

• episode of atrial fibrillation in the previous year
• BMI \> o = 27Kg/m2
• AHI \>30 o con 15\<AHI\<30 associated with other symptoms (sleeplessness, uncontrolled hypertension and cerebral events)

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20145, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation; Carnevale syndrome

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2025
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (1)