Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation (STAROSA)

March 4, 2024 updated by: University Hospital, Antwerp

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Symptomatic AF patients
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).
Device: (Cardio)Respiratory polygraphy (NOX T3s)
This home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI).
Diagnostic test: Polysomnography
Polysomnography allows both sleep and respiration monitoring during an overnight stay in a dedicated sleep clinic.
Device: 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: Fitbit smartwatch
The smartwatch enables the semi-continuous monitoring of the heart rhythm via the installed FibriCheck algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the entire duration of the study (2 periods of 3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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
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
CPAP/BiPAP/ASV compliance will be read out from the device.
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
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
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.
24 hours after the one-time use of the polygraphy device
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.
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
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
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.
Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Right after using the polygraphy device
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.
Right after the first and second period of 3 months of semi-continuous monitoring with the Fitbit smartwatch
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.
After the first and second period of 3 months of FibriCheck monitoring with the smartphone
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.
After the first and second period of 3 months of FibriCheck monitoring with the smartphone
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.
Immediately after the polysomnography examination
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.
During study completion after 6months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Hasselt University
Jessa Hospital
Universiteit Antwerpen

Investigators

  • Principal Investigator: Hein Heidbuchel, MD, PhD, University Hospital of Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2024

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUN B3002023000204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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