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

Study acronym: STAROSA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Secondary endpoints: 9 to 10v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2024 to Feb 23, 2024
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised at 2 of 2 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06263608
Lead Sponsor University Hospital, Antwerp
Collaborators: Jessa Hospital, Hasselt University, Universiteit Antwerpen
Conditions
(from sponsor)		 Atrial Fibrillation, Obstructive Sleep Apnea
Related terms Atrial Fibrillation, Sleep Apnea, Obstructive
Enrollment 209 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov