Fact CheckerSign in

NCT06263608Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 8 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
209 (estimated)
First submitted
31 Jan 2024
Start date
23 Feb 2024
Primary completion date
Feb 2028
Lead sponsor
University Hospital, Antwerp
NCT number
NCT06263608

What you commit to

  • Study type: Interventional
  • Planned participants: 209
  • From 23 Feb 2024 to the primary completion date, Feb 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior/recent polysomnography evaluation
  • Prior/active CPAP/BiPAP/ASV treatment

Other illness

  • Cognitive impairment
  • Pacemaker-dependent heart rhythm

Other

  • Patients diagnosed with permanent AF or only atrial flutter
  • Inability to speak or fully understand Dutch

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital of Antwerp
Coordinator of this site? Confirm its status
EdegemBelgiumRecruiting
Jessa Hospital
Coordinator of this site? Confirm its status
HasseltBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.