DANish Patients With Atrial Fibrillation and Sleep Apnea Prevalence by Night Owl (DANAPNO)
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| ClinicalTrials.gov Identifier: NCT04760002 |
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Recruitment Status :
Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Obstructive Sleep Apnea | Device: NightOwl |
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
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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. |
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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.
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)
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
| Contact: Mads Hashiba Jensen, med.stud | +45 28779403 | madshashiba@gmail.com |
| Denmark | |
| Herlev-Gentofte Hospital | Recruiting |
| Copenhagen, Denmark | |
| Contact: Morten Lamberts, MD, PhD | |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |