Atrial FibrillationSTAROSANCT06263608
Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
A study testing (Cardio)Respiratory polygraphy (NOX T3s), Polysomnography and Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV) in people with Atrial Fibrillation and Obstructive Sleep Apnea, run by University Hospital, Antwerp at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Obstructive Sleep Apnea
- What is being tested?
- (Cardio)Respiratory polygraphy (NOX T3s), Polysomnography and Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 2 sitesBelgium
- Study dates
- 23 Feb 2024to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
University Hospital of Antwerp
Edegem
Lien Desteghe, MSc PhD, lien.desteghe@uza.be
- Recruiting
Jessa Hospital
Hasselt
Lien Desteghe, MSc PhD, lien.desteghe@jessazh.be
About this study
Official 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, symptom burden and alcohol consumption questionnaires twice: right after the polysomnography examination and after the 3-month treatment.
Read the 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.
- Conditions
- Atrial Fibrillation, Obstructive Sleep Apnea
- Being tested
- (Cardio)Respiratory polygraphy (NOX T3s), Polysomnography, Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV), Fitbit smartwatch
- Keywords
- Atrial fibrillation, Obstructive sleep apnea, Cardiorespiratory polygraphy, Continuous positive airway pressure, Mobile health technology
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Cardio)Respiratory polygraphy (NOX T3s)Device
This home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI).
PolysomnographyDiagnostic test
Polysomnography 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)Device
Devices can be used to deliver CPAP, BiPAP, or ASV treatment to open up the airways, making breathing during sleep possible.
Fitbit smartwatchDevice
The smartwatch enables the semi-continuous monitoring of the heart rhythm via the installed FibriCheck algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic AF patients | Other | Eligible participants will use the NOX T3s polygraphy device for one night at home. If they have a positive obstructive sleep apnea diagnosis, they will be referred to a polysomnography examination, and subsequently treatment. Participants will also receive 3 to 6 months of semi-continuous heart rhythm monitoring with the Fitbit smartwatch (depending on whether they get treatment after obstructive sleep apnea diagnosis via polysomnography). Receives: Device: (Cardio)Respiratory polygraphy (NOX T3s); Diagnostic Test: Polysomnography; Device: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV); Device: Fitbit smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF burden before and after CPAP treatment
The AF burden will be measured via semi-continuous FibriCheck measurements via a Fitbit smartwatch.
Measured: During the entire duration of the study (2 periods of 3 months)
Secondary outcomes (10)
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.
Measured: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination
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
Measured: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination
Total sleep apnea burden
The total sleep apnea burden will be measured by the CPAP/BiPAP/ASV device
Measured: On average 3 months after initiation of obstructive sleep apnea treatment
CPAP/BiPAP/ASV compliance
CPAP/BiPAP/ASV compliance will be read out from the device.
Measured: On average 3 months after initiation of obstructive sleep apnea treatment
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.
Measured: 3 months after first and after second period of semi-continuous monitoring with Fitbit smartwatch
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.
Measured: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
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.
Measured: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
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.
Measured: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
Polygraphy negative patients
The number of polygraphy-negative patients in a general AF population will be calculated.
Measured: 24 hours after the one-time use of the polygraphy device
Patients' alcohol consumption assessed by the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) supplemented with four additional questions related to alcohol consumption
This questionnaire on alcohol consumption includes the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) supplemented with four additional questions related to alcohol consumption. The AUDIT-C consists of three questions, which can help identify who may have an active alcohol use disorder. It is scored on a scale of 0 to 12 points, with 0 points indicating no alcohol use in the past year. A higher AUDIT-C score suggests a greater likelihood of adverse effects on the individual's health and safety. The four additional questions inquire about the weekly consumption of alcohol-containing drinks, the type of drinks, their effects on sleep, and their impact on AF symptoms.
Measured: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start23 Feb 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, Hasselt University, Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Hein Heidbuchel, MD, PhD, Principal investigator, University Hospital of Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263608
- Sponsor's protocol ID
- BUN B3002023000204
- Acronym
- STAROSA
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2024
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAROSA Trial - Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06263608
- Acronym / sponsor ID
- STAROSA / BUN B3002023000204
- Conditions
- Atrial Fibrillation, Obstructive Sleep Apnea
- Keywords
- Atrial fibrillation, Obstructive sleep apnea, Cardiorespiratory polygraphy, Continuous positive airway pressure, Mobile health technology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Jessa Hospital, Hasselt University, Universiteit Antwerpen
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic AF patients | Other | Device: (Cardio)Respiratory polygraphy (NOX T3s), Diagnostic Test: Polysomnography, Device: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV), Device: Fitbit smartwatchEligible participants will use the NOX T3s polygraphy device for one night at home. If they have a positive obstructive sleep apnea diagnosis, they will be referred to a polysomnography examination, and subsequently treatment. Participants will also receive 3 to 6 months of semi-continuous heart rhythm monitoring with the Fitbit smartwatch (depending on whether they get treatment after obstructive sleep apnea diagnosis via polysomnography). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Cardio)Respiratory polygraphy (NOX T3s)This home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI). | Device | Symptomatic AF patients |
| PolysomnographyPolysomnography allows both sleep and respiration monitoring during an overnight stay in a dedicated sleep clinic. | Diagnostic test | Symptomatic AF patients |
| Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV)Devices can be used to deliver CPAP, BiPAP, or ASV treatment to open up the airways, making breathing during sleep possible. | Device | Symptomatic AF patients |
| Fitbit smartwatchThe smartwatch enables the semi-continuous monitoring of the heart rhythm via the installed FibriCheck algorithm. | Device | Symptomatic AF patients |
Primary outcome
AF burden before and after CPAP treatment
Time frame: During the entire duration of the study (2 periods of 3 months)
The AF burden will be measured via semi-continuous FibriCheck measurements via a Fitbit smartwatch.
10 secondary outcomes
Obstructive sleep apnea severity agreement between polygraphy and polysomnography
Time frame: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination
False positive rate of polygraphy
Time frame: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination
Total sleep apnea burden
Time frame: On average 3 months after initiation of obstructive sleep apnea treatment
CPAP/BiPAP/ASV compliance
Time frame: On average 3 months after initiation of obstructive sleep apnea treatment
Sleep score
Time frame: 3 months after first and after second period of semi-continuous monitoring with Fitbit smartwatch
Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ)
Time frame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ)
Time frame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS)
Time frame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
Polygraphy negative patients
Time frame: 24 hours after the one-time use of the polygraphy device
Patients' alcohol consumption assessed by the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) supplemented with four additional questions related to alcohol consumption
Time frame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hein Heidbuchel, MD, PhD principal investigator
University Hospital of Antwerp
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Cardio)Respiratory polygraphy (NOX T3s), Polysomnography and Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV) in people with Atrial Fibrillation and Obstructive Sleep Apnea, run by University Hospital, Antwerp at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lien Desteghe, MSc, PhD (+32 3 821 33 06, lien.desteghe@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF burden before and after CPAP treatment (time frame: During the entire duration of the study (2 periods of 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.