An observational study in Atrial Fibrillation and Osa Syndrome, sponsored by Istituto Auxologico Italiano. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by Istituto Auxologico Italiano · Observational
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 343 is above the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Inclusion Criteria primary outcome:
Inclusion Criteria secondary outcome:
Exclusion Criteria:
Study of the sleep pattern
Weight loss counselling
Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation
Change in prevalence of obstructive sleep apnoea from baseline to 3 years
Time frame: 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
Time frame: Baseline
Change in body weight
Change in body weight from baseline to 3 years
Time frame: Baseline and at 3, 6, 12, 24 and 36 months
Change in incidence of atrial fibrillation recurrencies
Change in incidence of atrial fibrillation recurrencies from baseline to 3 years
Time frame: Baseline and at 3, 6, 12, 24 and 36 months
Change in quality of life
Change in quality of life from baseline to 3 years
Time frame: Baseline and at 3, 6, 12, 24 and 36 months
Ran from Jan 2020 to primary completion in Dec 2022, 35 months.
Of 536 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 85. This study's 35 months is below that.
Counting every sponsor, half of 685 studies reached it within 38 months; a quarter within 22 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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