Clinical trial NCT06263608: Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
Official title: STAROSA Trial - Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Obstructive Sleep Apnea
Keywords: Atrial fibrillation
Obstructive sleep apnea
Cardiorespiratory polygraphy
Continuous positive airway pressure
Mobile health technology
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: Hasselt University
name: Universiteit Antwerpen
First posted: 2024-02-16
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Atrial fibrillation (AF) is the most prevalent arrhythmia globally. Research has shown that AF is associated with various risk factors such as hypertension, diabetes, obesity, and obstructive sleep apnea. Obstructive sleep apnea is a sleep-disordered breathing condition that is highly prevalent in AF patients, contributing to the development and progression of AF.

Despite the high prevalence of obstructive sleep apnea in AF patients (about 62%), it often goes underrecognized and underdiagnosed. Lack of symptom reporting and easily accessible screening tools and strategies contribute to this underdiagnosis. The standard diagnostic method is through polysomnography, which, while effective, has drawbacks such as high costs, labor intensity, and time-consuming nature, making it challenging to use as a screening tool. (Cardio)respiratory polygraphy devices, such as the NOX-T3s, are gaining interest for obstructive sleep apnea detection due to their user-friendly nature, comfort, convenience, and home useability. A previous validation study showed that the NOX-T3s polygraphy device had high accuracy, sensitivity, and specificity and was also the most user-friendly for obstructive sleep apnea detection in AF patients.

Besides the screening, retrospective research has shown that obstructive sleep apnea treatment with the gold standard method, continuous positive airway pressure (CPAP), positively influences AF recurrence through improved antiarrhythmic therapy. Current literature suggests early obstructive sleep apnea diagnosis, followed by early CPAP treatment, could reduce AF recurrence. However, prospective studies supporting this are lacking. Therefore, additional information on the heart rhythm of AF patients, monitored in a (semi)-continuous manner before and after treatment initiation, would be valuable to investigate if treatment (mostly CPAP) leads to a reduction in AF events.

However, implementing a care pathway using the NOX T3s for structured obstructive sleep apnea testing and the Fitbit Versa smartwatch with the FibriCheck algorithm for the follow-up of AF recurrence in standard clinical care in an AF population still needs to be evaluated.

Eligibility criteria: 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

Primary outcomes:
measure: AF burden before and after CPAP treatment
timeFrame: During the entire duration of the study (2 periods of 3 months)
Secondary outcomes:
measure: Obstructive sleep apnea severity agreement between polygraphy and polysomnography
timeFrame: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination
measure: False positive rate of polygraphy
timeFrame: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination
measure: Total sleep apnea burden
timeFrame: On average 3 months after initiation of obstructive sleep apnea treatment
measure: CPAP/BiPAP/ASV compliance
timeFrame: On average 3 months after initiation of obstructive sleep apnea treatment
measure: Sleep score
timeFrame: 3 months after first and after second period of semi-continuous monitoring with Fitbit smartwatch
measure: Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ)
timeFrame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ)
timeFrame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS)
timeFrame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
measure: Polygraphy negative patients
timeFrame: 24 hours after the one-time use of the polygraphy device
Other outcomes:
measure: User-friendliness of the NOX T3s polygraphy device
timeFrame: Right after using the polygraphy device
measure: User-friendliness of the Fitbit-based FibriCheck monitoring
timeFrame: Right after the first and second period of 3 months of semi-continuous monitoring with the Fitbit smartwatch
measure: Uptake rate of the advice to patients to undergo a polysomnography examination
timeFrame: Immediately after the polysomnography examination
measure: Protocol adherence to smartphone heart rhythm measurements
timeFrame: After the first and second period of 3 months of FibriCheck monitoring with the smartphone
measure: The quality of the FibriCheck measurements
timeFrame: After the first and second period of 3 months of FibriCheck monitoring with the smartphone
measure: Number of technical issues
timeFrame: During study completion after 6months of follow-up
Locations:
city: Edegem
country: Belgium
facility: University Hospital of Antwerp
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
affiliation: University Hospital of Antwerp
name: Hein Heidbuchel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: