Assessment of Sleep Parameters Using Polygraphy in Patients With Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study (AAHI Study)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Objective: To assess sleep parameters using polygraphy in the course of treatment of patients with paroxysmal atrial fibrillation qualified for pulmonary vein isolation. Study Procedures: The study involves four polygraphic sleep studies (two before and two after atrial fibrillation ablation), each conducted at least 7 days apart. The polygraphic studies will record the following parameters: pulse oximetry, heart rate, respiratory movements of the chest, and airflow through the anterior nares. The study includes only patients undergoing atrial fibrillation ablation for the first time. Risks and Benefits: The study is non-invasive and does not involve any direct health risks. Participation will not affect your treatment process, but it may provide valuable information about your health status. Voluntary Participation: Participation in the study is entirely voluntary. You may withdraw from the study at any time without providing a reason and without any impact on your ongoing medical treatment. Personal Data Protection (GDPR): In accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation - GDPR): The data controller is Primula Clinics sp. z o.o. Personal data will be processed solely for the purpose of conducting this study. Data will be stored no longer than required by law or necessary for the research purposes. You have the right to access your data, request its correction, deletion, restriction of processing, and to object to data processing. All data will be protected against unauthorized access.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of atrial fibrillation (AFib) and scheduled catheter ablation.

• Presence of at least one OSA risk factor: hypertension, male sex, BMI \> 25, diabetes, excessive daytime sleepiness, snoring.

Locations
Other Locations
Poland
Primula Clinics
RECRUITING
Grodzisk Mazowiecki
Contact Information
Primary
Paweł S Basiukiewicz, MD, PhD
pbasiukiewicz@gmail.com
+48 698612826
Backup
Piotr Futyma, MD, PhD
piotr.futyma@gmail.com
+48 533503044
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 100
Treatments
Afib scheduled for PVI, at least one risk factor for obstructive sleep apnea.
Sponsors
Leads: Primula Clinics

This content was sourced from clinicaltrials.gov