PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF (PROSERPin-AF)

March 13, 2023 updated by: Istituto Auxologico Italiano

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

343

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20145
        • Istituto Auxologico Italiano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and at 3, 6, 12, 24 and 36 months
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and at 3, 6, 12, 24 and 36 months
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
Baseline and at 3, 6, 12, 24 and 36 months
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
Baseline and at 3, 6, 12, 24 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Anticipated)

January 31, 2025

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09C020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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