[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612870":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":11,"centralContacts":15,"locations":24,"responsibleParty":40,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":26,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Primula Clinics","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":10},"Afib scheduled for PVI, at least one risk factor for obstructive sleep apnea.",null,[12],{"name":13,"affiliation":5,"role":14},"Paweł S Basiukiewicz, MD, PhD","PRINCIPAL_INVESTIGATOR",[16,20],{"name":13,"role":17,"phone":18,"phoneExt":10,"email":19},"CONTACT","+48 698612826","pbasiukiewicz@gmail.com",{"name":21,"role":17,"phone":22,"phoneExt":10,"email":23},"Piotr Futyma, MD, PhD","+48 533503044","piotr.futyma@gmail.com",[25],{"facility":5,"status":26,"city":27,"state":10,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"RECRUITING","Grodzisk Mazowiecki","05-825","Poland","PL",{"type":32,"coordinates":33},"Point",[34,35],20.6337,52.10387,{"lat":35,"lon":34},[38],{"name":39,"role":17,"phone":18,"phoneExt":10,"email":19},"Paweł Basiukiewicz, MD, PhD",{"type":41,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100612870","impact-of-atrial-fibrillation-ablation-on-sleep-parameters-100612870",false,"NCT07259200","Impact of Atrial Fibrillation Ablation on Sleep Parameters.","Assessment of Sleep Parameters Using Polygraphy in Patients With Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study (AAHI Study)","AAHI","Inclusion Criteria (all must be met):\n\n* Diagnosis of atrial fibrillation (AFib) and scheduled catheter ablation.\n* Presence of at least one OSA risk factor: hypertension, male sex, BMI \\> 25, diabetes, excessive daytime sleepiness, snoring.\n\nExclusion Criteria:\n\n\\- Absence of predefined sleep apnea risk factors.","ALL","18 Years",{"count":53,"type":54},100,"ESTIMATED","OBSERVATIONAL","Assessment of Sleep Parameters Using Polygraphy in Patients with Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study: Afib Ablation and Hypopnea Index - The \"AAHI\" Study\n\nPrincipal Investigator:\n\nDr. Paweł Basiukiewicz, MD, PhD\n\nStudy Sponsor:\n\nPrimula Clinics sp. z o.o. Żyrardowska 31, 05-825 Grodzisk Mazowiecki, Poland NIP (Tax ID): 529 183 03 11\n\nDear Sir\u002FMadam,\n\nYou have been invited to participate in a scientific study aimed at assessing sleep parameters in patients with atrial fibrillation undergoing rhythm-control therapy. Please read this document carefully before deciding whether to take part in the study. If you have any questions, please contact the principal investigator.\n\nStudy Objective:\n\nTo assess sleep parameters using polygraphy in the course of treatment of patients with paroxysmal atrial fibrillation qualified for pulmonary vein isolation.\n\nStudy Procedures:\n\nThe study involves four polygraphic sleep studies (two before and two after atrial fibrillation ablation), each conducted at least 7 days apart.\n\nThe polygraphic studies will record the following parameters: pulse oximetry, heart rate, respiratory movements of the chest, and airflow through the anterior nares.\n\nThe study includes only patients undergoing atrial fibrillation ablation for the first time.\n\nRisks and Benefits:\n\nThe 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.\n\nVoluntary Participation:\n\nParticipation 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.\n\nPersonal Data Protection (GDPR):\n\nIn accordance with Regulation (EU) 2016\u002F679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation - GDPR):\n\nThe data controller is Primula Clinics sp. z o.o.\n\nPersonal data will be processed solely for the purpose of conducting this study.\n\nData will be stored no longer than required by law or necessary for the research purposes.\n\nYou have the right to access your data, request its correction, deletion, restriction of processing, and to object to data processing.\n\nAll data will be protected against unauthorized access.",[58,59,60],"Atrial Fibrillation (AF)","OSA - Obstructive Sleep Apnea","Pulmonary Vein Isolation",[62,63,64,65,66,67,68,69,70],"atrial fibrillation","sleep apnea","sleep apnoea","ablation","pulmonary vein isolation","pvi","snoring","choking","somnolence","2025-11-26",{"date":73,"type":74},"2025-12-02","ACTUAL",{"date":76,"type":74},"2025-03-20",{"date":78,"type":54},"2026-02-28",{"name":5,"class":6},1]