NCT06188247Completed
Pilot-trial Testing Remote Sleep Apnea Evaluation in Patients with Atrial Fibrillation
Pilot for a National Virtual Trial Testing Remote Sleep Apnea Evaluation in Patients with Atrial Fibrillation - (Mini VIR-SAAF)
Source: ClinicalTrials.gov · Last updated 29 Jan 2025
Brief summary (registry, in English)
This is an investigator-initiated virtual (or decentralized) trial that includes a postal parcel (mail-in) containing sensors for SA diagnosis (NightOwl™) and physical activity (SENS Motion), in addition to smart-phone based heart rhythm (FibriCheck) monitoring in participants with paroxysmal or persistent AF. A case-coordinator (the investigators) will manage all participant contacts virtually during the study from inclusion to follow-up.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 18 Dec 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Herlev and Gentofte Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06188247
What you commit to
- Study type: Interventional
- Participants enrolled: 25
- From 1 Dec 2023 to the primary completion date, 1 Jul 2024
- 1 site 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
- Previous investigation for sleep-disturbed breathing
Other illness
- Advanced heart failure (left ventricular dysfunction and NYHA III/IV)
- Peripheral arterial disease with daily intermittent claudication
Other
- Occupational driver licenses
- Pregnancy
- Doxazosin or Terazosin (alpha-adrenergic antagonists)
Who the study is looking for
- Age\>18 years
- Established paroxysmal or persistent AF diagnosis
- Owning a compatible smartphone (or accepting a smart phone provided by the investigators)
- Understanding of potential SA treatment possibilities including CPAP treatment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herlev and Gentofte Hospital Coordinator of this site? Confirm its status | Gentofte Municipality | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.