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

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ClinicalTrials.gov Identifier: NCT04760002
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Collaborators:
Ectosense NV
Sygekassernes Helsefond
Information provided by (Responsible Party):
Morten Lamberts, Herlev and Gentofte Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Device: NightOwl

Detailed Description:

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.

  1. Initial visit with time for clinical evaluation, questionnaire of OSA symptoms, theparticipant borrows a NightOwl and receive device instructions.
  2. Four night of recording with NightOwl™ in home environment.
  3. Follow-up visit for the home-monitoring results and soft node questionnaire.
  4. 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

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: Danish Patients With Atrial Fibrillation and Sleep Apnea Prevalence by Night Owl
Actual Study Start Date : January 25, 2021
Estimated Primary Completion Date : June 25, 2021
Estimated Study Completion Date : December 25, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Atrial Fibrillation Patients

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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  1. Diagnosis of AF of any type
  2. Age < 90 years
  3. Age >18 years

Exclusion Criteria:

  1. Known sleep apnea
  2. Secondary AF (post-surgical, due to infection, thyroid-induced)
  3. Known or newly discovered severe ventricular ectopic beats (as defined by the NightOwl manual)
  4. Professional drivers
  5. Severe heart failure (New York Heart Association class III or IV)
  6. Severe chronic obstructive pulmonary disease (use of home oxygen)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760002


Contacts
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Contact: Mads Hashiba Jensen, med.stud +45 28779403 madshashiba@gmail.com

Locations
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Denmark
Herlev-Gentofte Hospital Recruiting
Copenhagen, Denmark
Contact: Morten Lamberts, MD, PhD         
Sponsors and Collaborators
Herlev and Gentofte Hospital
Ectosense NV
Sygekassernes Helsefond
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Morten Lamberts, MD, PhD, Associate professor, Consultant Cardiology,, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT04760002    
Other Study ID Numbers: P-2021-57
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases