Obstructive Sleep ApneaDANAPNONCT04760002
DANish Patients With Atrial Fibrillation and Sleep Apnea Prevalence by Night Owl
An observational study of Obstructive Sleep Apnea, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- NightOwl
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Jan 2021to 1 Jan 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of AF of any type
- Age < 90 years
- Age >18 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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
- Conditions
- Obstructive Sleep Apnea
- Being tested
- NightOwl
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NightOwlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: NightOwl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start25 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 126 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sygekassernes Helsefond
- Responsible party
- Principal investigator, Morten Lamberts, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760002
- Sponsor's protocol ID
- P-2021-57
- Acronym
- DANAPNO
- Status last verified
- Mar 2023
- First submitted
- 15 Feb 2021
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen MH, Dalgaard F, Laub RR, Gottlieb V, Hansen ML, Vendelboe O, Hansen J, Lamberts M. Protocol for detecting unrecognized sleep apnea in patients with atrial fibrillation by a home-monitoring device: the DAN-APNO study. BMC Cardiovasc Disord. 2022 Jan 8;22(1):6. doi: 10.1186/s12872-021-02453-0.
PubMed 34998370
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Patients With Atrial Fibrillation and Sleep Apnea Prevalence by Night Owl
- ClinicalTrials.gov ID
- NCT04760002
- Acronym / sponsor ID
- DANAPNO / P-2021-57
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Sygekassernes Helsefond
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation Patients | – | Device: NightOwlAtrial fibrillation patients are to be investigated for sleep apnea by the a home-monitoring device. Other inclusion criteria are: >18 years <90 years |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of AF of any type
- Age < 90 years
- Age >18 years
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NightOwlThe 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. | Device | Atrial Fibrillation Patients |
Primary outcome
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.
1 secondary outcome
Correlation between NightOwl and cardio-respiratory monitoring
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Derived from this study: PubMed 34998370Jensen MH, Dalgaard F, Laub RR, Gottlieb V, Hansen ML, Vendelboe O, Hansen J, Lamberts M. Protocol for detecting unrecognized sleep apnea in patients with atrial fibrillation by a home-monitoring device: the DAN-APNO study. BMC Cardiovasc Disord. 2022 Jan 8;22(1):6. doi: 10.1186/s12872-021-02453-0.
- Ectosense - NightOwl deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of obstructive sleep apnea in atrial fibrillation patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.