An observational study in Obstructive Sleep Apnea, sponsored by Herlev and Gentofte Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Herlev and Gentofte Hospital · Observational
A project of the feasibility of using NightOwl to detect the prevalence of obstructive sleep apnea (OSA) in patients with atrial fibrillation (AF). The long-term aim is to use the device to screen for OSA in a randomized clinical trial in AF patients undergoing ablation and/or a randomized trial of AF patients undergoing cardioversion.
Patients diagnosed with any type of AF referred to anticoagulation initiation at a nurse-run ambulatory will beasked to participate. The ambulatory consists of four daily nurse-led tracks at Department ofCardiology, Herlev-Gentofte University Hospital. In a formal collaboration, Department ofPulmonology, Herlev-Gentofte University Hospital provides work-up with cardio-respiratory monitoring investigation and clinical evaluation of initiating treatment of sleep apnea in patients referred from the study. ParticipantsParticipants with AF, without known sleep apnea, and indication for anticoagulation will be recruited from the Thrombosis unit (Tromboseklinikken) at Herlev-GentofteHospital. Participants will be contacted and asked of participation in the research project by a local investigator or a project nurse as part of their standard check at the anticoagulation outpatient clinic at Herlev and Gentofte Hospital. The conversation will include verbal participant information about the research project and about the right of time to consider recruitment. The written participant information will be handed to the participants prior to the verbal information, and it will be handed to the participants by a researcher with thorough knowledge to the project or a project nurse. The information needed for finding qualified participants, before a written informed consent is obtained, will be passed on to the investigators. The written informed consent allows the researchers to obtain necessary information for the project in the participant's medical health records
Study Design:
The is a cross sectional study. In total two visits will be planned, with a third visit for the first 20 participants and participants with apnea-hypopnea index (AHI)>15 included in the study.
The time plan for the study inclusion until last patient enrolled are estimated to be approximately 6months
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 470 are open to participants now.
This study's enrollment of 126 is above the median of 104 across 648 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Herlev and Gentofte Hospital is the lead sponsor of 72 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with AF referred to anticoagulation initiation at a nurse-run ambulatory will be asked to participate.
Participants will be recruited from the Thrombosis unit (Tromboseklinikken) at Herlev-Gentofte Hospital. Patient reporting of symptoms for sleep apnea is not included as inclusion or exclusion criteria.
Exclusion Criteria:
Atrial fibrillation patients are to be investigated for sleep apnea by the a home-monitoring device. Other inclusion criteria are: \>18 years \<90 years
Device: NightOwl
The NightOwl consists of a small sensor device which is placed on the fingertip and a smartphone app that is connected to an encrypted cloud-based analytics platform within the European Union, the NightOwl software. It is self-applied by attaching the sensor to the fingertip by means of an adhesive patch. The NightOwl sensor acquires accelerometer data and reflectancebased photoplethysmography (PPG) from which it derives actigraphy (sleep/wake behavior), SpO2, peripheral artery tone (PAT) and pulse rate, among other features. A PAT analysis derives changes in caliber of arteries elicited by alterations in the contractile activity of vascular smooth muscle and are referred to as changes in arterial tone. The end state of the apnea-hypopnea events are associated with sympathetic activation.
Prevalence of obstructive sleep apnea in atrial fibrillation patients
The primary outcome of the study is the prevalence with 95% confidence intervals of obstructive sleep apnea in atrial fibrillation patients detected by NightOwl.
Time frame: 6 months
Correlation between NightOwl and cardio-respiratory monitoring
The secondary outcome will be correlation between NightOwl and cardio-respiratory diagnostic testing for obstructive sleep apnea and correlation between obstructive sleep apnea screening questionnaire for cardio-respiratory and NightOwl.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Herlev and Gentofte Hospital