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NCT Number: NCT06263608

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.

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Key information

Conditions

Atrial Fibrillation Apnea Arrhythmias, Cardiac Cardiovascular Diseases Dyssomnias Heart Diseases Nervous System Diseases Obstructive Sleep Apnea Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Antwerp, Edegem, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(Cardio)Respiratory polygraphy (NOX T3s)

Device

This home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI).

Polysomnography

Diagnostic 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 smartwatch

Device

The smartwatch enables the semi-continuous monitoring of the heart rhythm via the installed FibriCheck algorithm.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Obstructive sleep apnea severity agreement between polygraphy and polysomnography

    Time frame: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination

    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.

  2. False positive rate of polygraphy

    Time frame: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination

    The false positive rate will be calculated using a polygraphy apnea-hypopnea index value for referral to the sleep clinic compared to polysomnography

  3. Total sleep apnea burden

    Time frame: On average 3 months after initiation of obstructive sleep apnea treatment

    The total sleep apnea burden will be measured by the CPAP/BiPAP/ASV device

  4. CPAP/BiPAP/ASV compliance

    Time frame: On average 3 months after initiation of obstructive sleep apnea treatment

    CPAP/BiPAP/ASV compliance will be read out from the device.

  5. Sleep score

    Time frame: 3 months after first and after second period of semi-continuous monitoring with Fitbit smartwatch

    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.

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

  9. Polygraphy negative patients

    Time frame: 24 hours after the one-time use of the polygraphy device

    The number of polygraphy-negative patients in a general AF population will be calculated.

  10. 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

    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.

Other outcomes

  1. User-friendliness of the NOX T3s polygraphy device

    Time frame: Right after using the 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.

  2. User-friendliness of the Fitbit-based FibriCheck monitoring

    Time frame: Right after the first and second period of 3 months of semi-continuous monitoring with the Fitbit smartwatch

    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.

  3. Uptake rate of the advice to patients to undergo a polysomnography examination

    Time frame: Immediately after the polysomnography examination

    The uptake rate will be evaluated by assessing the number of scheduled polysomnography examination in patients with a positive polygraphy test.

  4. Protocol adherence to smartphone heart rhythm measurements

    Time frame: After the first and second period of 3 months of FibriCheck monitoring with the smartphone

    The FibriCheck report will be used to evaluate whether patients were adherent to performing at least 2 spot-check measurements daily.

  5. The quality of the FibriCheck measurements

    Time frame: After the first and second period of 3 months of FibriCheck monitoring with the smartphone

    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.

  6. Number of technical issues

    Time frame: During study completion after 6months of follow-up

    A troubleshooting document will be set up in which solutions will be recorded in the case of technical difficulties regarding the used devices.

Study contacts

Contact information is provided by the study sponsor or research team.

Lien Desteghe, MSc, PhD

CONTACT

[email protected]

+32 3 821 33 06

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Hasselt University
  • Jessa Hospital
  • Universiteit Antwerpen

Registry information

Official study title

STAROSA Trial - Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation

Acronym: STAROSA

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 16, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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