PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF

NCT ID: NCT05784077

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Osa Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Polysomnography

Study of the sleep pattern

Intervention Type DIAGNOSTIC_TEST

Lifestyle counselling

Weight loss counselling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 1 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)

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Auxologico Italiano

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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09C020

Identifier Type: -

Identifier Source: org_study_id

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