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PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF

Prevalenza Delle Apnee Notturne e Riduzione Dei Fattori Promotori Nella Fibrillazione Atriale

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05784077
Acronym
PROSERPin-AF
Enrollment
343
Registered
2023-03-24
Start date
2020-01-01
Completion date
2025-01-31
Last updated
2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Osa Syndrome

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.

Interventions

DIAGNOSTIC_TESTPolysomnography

Study of the sleep pattern

Weight loss counselling

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillationBaseline and at 3, 6, 12, 24 and 36 monthsChange in prevalence of obstructive sleep apnoea from baseline to 3 years
Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillationBaselinePercentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation

Secondary

MeasureTime frameDescription
Change in body weightBaseline and at 3, 6, 12, 24 and 36 monthsChange in body weight from baseline to 3 years
Change in incidence of atrial fibrillation recurrenciesBaseline and at 3, 6, 12, 24 and 36 monthsChange in incidence of atrial fibrillation recurrencies from baseline to 3 years
Change in quality of lifeBaseline and at 3, 6, 12, 24 and 36 monthsChange in quality of life from baseline to 3 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026