Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp
About this trial
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, symptom burden and alcohol consumption questionnaires twice: right after the polysomnography examination and after the 3-month treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patients diagnosed with permanent AF or only atrial flutter
Prior/recent polysomnography evaluation
Prior/active CPAP/BiPAP/ASV treatment
Cognitive impairment
Trial design
Design model
Single group
Treatments tested in this trial
(Cardio)Respiratory polygraphy (NOX T3s)
DeviceThis home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI).
Polysomnography
Diagnostic testPolysomnography allows both sleep and respiration monitoring during an overnight stay in a dedicated sleep clinic.
Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV)
DeviceDevices can be used to deliver CPAP, BiPAP, or ASV treatment to open up the airways, making breathing during sleep possible.
Fitbit smartwatch
DeviceThe smartwatch enables the semi-continuous monitoring of the heart rhythm via the installed FibriCheck algorithm.
Treatment groups
209 Participants
are divided into 1 treatment groupGroup A: Symptomatic AF patientsOther 4 interventions
Trial outcomes
Primary outcomes
1
AF burden before and after CPAP treatment
The AF burden will be measured via semi-continuous FibriCheck measurements via a Fitbit smartwatch.
Time frame
During the entire duration of the study (2 periods of 3 months)Secondary outcomes
1
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.
Time frame
Result known after polysomnography examination, on average 6 weeks after the polysomnography examination2
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
Time frame
Result known after polysomnography examination, on average 6 weeks after the polysomnography examination3
Total sleep apnea burden
The total sleep apnea burden will be measured by the CPAP/BiPAP/ASV device
Time frame
On average 3 months after initiation of obstructive sleep apnea treatment4
CPAP/BiPAP/ASV compliance
CPAP/BiPAP/ASV compliance will be read out from the device.
Time frame
On average 3 months after initiation of obstructive sleep apnea treatmentOther outcomes
1
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.
Time frame
Right after using the polygraphy device2
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.
Time frame
Right after the first and second period of 3 months of semi-continuous monitoring with the Fitbit smartwatch3
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.
Time frame
Immediately after the polysomnography examination4
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.
Time frame
After the first and second period of 3 months of FibriCheck monitoring with the smartphoneSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Antwerp
Lead sponsor
Jessa Hospital
Collaborator
Hasselt University
Collaborator
Universiteit Antwerpen
Collaborator
Source ClinicalTrials.gov