protocolSection identificationModule nctId: NCT06263608, orgStudyIdInfo id: BUN B3002023000204, briefTitle: Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation, acronym: STAROSA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2028-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University Hospital, Antwerp, class: OTHER, collaborators name: Jessa Hospital, collaborators name: Hasselt University, collaborators name: Universiteit Antwerpen, descriptionModule briefSummary: The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population.Participants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction and symptom burden questionnaires twice: right after the polysomnography examination and after the 3-month treatment., conditionsModule conditions: Atrial Fibrillation, conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 209, type: ESTIMATED, armsInterventionsModule interventions name: (Cardio)Respiratory polygraphy (NOX T3s), interventions name: Polysomnography, interventions name: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV), interventions name: Fitbit smartwatch, outcomesModule primaryOutcomes measure: AF burden before and after CPAP treatment, secondaryOutcomes measure: Obstructive sleep apnea severity agreement between polygraphy and polysomnography, secondaryOutcomes measure: False positive rate of polygraphy, secondaryOutcomes measure: Total sleep apnea burden, secondaryOutcomes measure: CPAP/BiPAP/ASV compliance, secondaryOutcomes measure: Sleep score, secondaryOutcomes measure: Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ), secondaryOutcomes measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ), secondaryOutcomes measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS), secondaryOutcomes measure: Polygraphy negative patients, otherOutcomes measure: User-friendliness of the NOX T3s polygraphy device, otherOutcomes measure: User-friendliness of the Fitbit-based FibriCheck monitoring, otherOutcomes measure: Uptake rate of the advice to patients to undergo a polysomnography examination, otherOutcomes measure: Protocol adherence to smartphone heart rhythm measurements, otherOutcomes measure: The quality of the FibriCheck measurements, otherOutcomes measure: Number of technical issues, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Antwerp, status: RECRUITING, city: Edegem, country: Belgium, contacts name: Lien Desteghe, MSc PhD, role: CONTACT, email: lien.desteghe@uza.be, geoPoint lat: 51.15662, lon: 4.44504, locations facility: Jessa Hospital, status: RECRUITING, city: Hasselt, country: Belgium, contacts name: Lien Desteghe, MSc PhD, role: CONTACT, email: lien.desteghe@jessazh.be, geoPoint lat: 50.93106, lon: 5.33781, hasResults: False