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OpenTrials
Completed

NCT Number: NCT04760002

DANish Patients With Atrial Fibrillation and Sleep Apnea Prevalence by Night Owl

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev-Gentofte Hospital

Copenhagen, Denmark

About this study

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.

  • Initial visit with time for clinical evaluation, questionnaire of OSA symptoms, theparticipant borrows a NightOwl and receive device instructions.
  • Four night of recording with NightOwl™ in home environment.
  • Follow-up visit for the home-monitoring results and soft node questionnaire.
  • For the 20 first patients and for all patients where the home test is showing (AHI>15) a fourth visit at the sleep apnea clinic will be arranged.

The time plan for the study inclusion until last patient enrolled are estimated to be approximately 6months

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of AF of any type
  • Age < 90 years
  • Age >18 years

Exclusion criteria

  • Known sleep apnea
  • Secondary AF (post-surgical, due to infection, thyroid-induced)
  • Known or newly discovered severe ventricular ectopic beats (as defined by the NightOwl manual)
  • Professional drivers
  • Severe heart failure (New York Heart Association class III or IV)
  • Severe chronic obstructive pulmonary disease (use of home oxygen)

Treatment and study plan

NightOwl

Device

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.

Primary outcomes

  1. Prevalence of obstructive sleep apnea in atrial fibrillation patients

    Time frame: 6 months

    The primary outcome of the study is the prevalence with 95% confidence intervals of obstructive sleep apnea in atrial fibrillation patients detected by NightOwl.

Secondary outcomes

  1. Correlation between NightOwl and cardio-respiratory monitoring

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

  • Sygekassernes Helsefond

Registry information

Acronym: DANAPNO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2021
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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