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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
University Hospital of Antwerp
RECRUITING
Edegem
Jessa Hospital
RECRUITING
Hasselt
Contact Information
Primary
Lien Desteghe, MSc, PhD
lien.desteghe@uza.be
+32 3 821 33 06
Time Frame
Start Date: 2024-02-23
Estimated Completion Date: 2028-02
Participants
Target number of participants: 209
Treatments
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).
Sponsors
Collaborators: Jessa Hospital, Hasselt University, Universiteit Antwerpen
Leads: University Hospital, Antwerp

This content was sourced from clinicaltrials.gov