Atrial Fibrillation Clinical Trial
— STAROSAOfficial title:
STAROSA Trial - Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
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.
Status | Recruiting |
Enrollment | 209 |
Est. completion date | February 2028 |
Est. primary completion date | February 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients in whom AF (paroxysmal or persistent) is diagnosed with a 12-lead ECG - Patients who experience symptoms of their AF (mEHRA = 2a) - Older than 18 years - Owning a smartphone compatible with Fitbit and FibriCheck applications (i.e. recent versions of Apple iOS or Android drivers) - Ability to sign the informed consent Exclusion Criteria: - Patients diagnosed with permanent AF or only atrial flutter - Prior/recent polysomnography evaluation - Prior/active CPAP/BiPAP/ASV treatment - Cognitive impairment - Inability to speak or fully understand Dutch - Pacemaker-dependent heart rhythm |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital of Antwerp | Edegem | |
Belgium | Jessa Hospital | Hasselt |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | Hasselt University, Jessa Hospital, Universiteit Antwerpen |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | User-friendliness of the NOX T3s polygraphy device | The patient reported experience measure questionnaire assesses the user-friendliness and patient satisfaction of the NOX T3s PG device. The minimum score is 0, the maximum score is 40. The higher the score, the more user-friendly the device. | Right after using the polygraphy device | |
Other | User-friendliness of the Fitbit-based FibriCheck monitoring | The patient reported experience measure questionnaire assesses the user-friendliness and patient satisfaction of the Fitbit smartwatch with FibriCheck monitoring. The minimum score is 0, the maximum score is 60. Additionally, patients are questioned about the type and long-term time of monitoring with FibriCheck. | Right after the first and second period of 3 months of semi-continuous monitoring with the Fitbit smartwatch | |
Other | Uptake rate of the advice to patients to undergo a polysomnography examination | The uptake rate will be evaluated by assessing the number of scheduled polysomnography examination in patients with a positive polygraphy test. | Immediately after the polysomnography examination | |
Other | Protocol adherence to smartphone heart rhythm measurements | The FibriCheck report will be used to evaluate whether patients were adherent to performing at least 2 spot-check measurements daily. | After the first and second period of 3 months of FibriCheck monitoring with the smartphone | |
Other | The quality of the FibriCheck measurements | The algorithm indicates low quality measurements. The number of low quality measurements will be evaluated during the follow-up compared to the good quality measurements. | After the first and second period of 3 months of FibriCheck monitoring with the smartphone | |
Other | Number of technical issues | A troubleshooting document will be set up in which solutions will be recorded in the case of technical difficulties regarding the used devices. | During study completion after 6months of follow-up | |
Primary | AF burden before and after CPAP treatment | The AF burden will be measured via semi-continuous FibriCheck measurements via a Fitbit smartwatch. | During the entire duration of the study (2 periods of 3 months) | |
Secondary | Obstructive sleep apnea severity agreement between polygraphy and polysomnography | The obstructive sleep apnea severity agreement between the NOX T3s polygraphy device and the in-hospital polysomnography examination will be assessed by evaluating AHI values. | Result known after polysomnography examination, on average 6 weeks after the polysomnography examination | |
Secondary | False positive rate of polygraphy | The false positive rate will be calculated using a polygraphy apnea-hypopnea index value for referral to the sleep clinic compared to polysomnography | Result known after polysomnography examination, on average 6 weeks after the polysomnography examination | |
Secondary | Total sleep apnea burden | The total sleep apnea burden will be measured by the CPAP/BiPAP/ASV device | On average 3 months after initiation of obstructive sleep apnea treatment | |
Secondary | CPAP/BiPAP/ASV compliance | CPAP/BiPAP/ASV compliance will be read out from the device. | On average 3 months after initiation of obstructive sleep apnea treatment | |
Secondary | Sleep score | The sleep score will be determined based on Fitbit data. The score is based on sleep duration, sleep quality, and restoration. The minimum value is 0 and the maximum value is 100. The higher the value, the better the overall sleep efficiency. | 3 months after first and after second period of semi-continuous monitoring with Fitbit smartwatch | |
Secondary | Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ) | The Leuven ARrhythmia Questionnaire (LARQ) will be used to assess the AF symptom profile based on six symptoms: palpitations, dyspnea, chest pain, syncope, dizziness, and fatigue. The minimum score is 0 and maximum score is 100. The higher the score, the more pronounced the symptom burden.(LARQ) before and after treatment. | Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment | |
Secondary | Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ) | The Berlin Questionnaire (BQ) will be used to assess the risk of sleep apnea focusing on 3 OSA symptoms (snoring, daytime sleepiness, and obesity/hypertension). For the first two symptoms, the category is positive if 2 points or more are given. The last category is positive if the patient has obesity and/or hypertension. | Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment | |
Secondary | Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS) | The Epworth Sleepiness Scale (ESS) will be used to assess the overall daytime sleepiness in eight situations. Minimum score is 0 and the maximum score is 24. The higher the score, the higher the chance for daytime sleepiness. | Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment | |
Secondary | Polygraphy negative patients | The number of polygraphy-negative patients in a general AF population will be calculated. | 24 hours after the one-time use of the polygraphy device |
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