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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-25

Study Completion Date

2023-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot-trial Testing Remote Sleep Apnea Evaluation in Patients with Atrial Fibrillation

NCT06188247

Atrial Fibrillation Sleep Apnea

COMPLETED NA

Evaluating the Impact of Home-Based Sleep Apnea Diagnostic on Well-Being, Health Behavior, and AF Load in Patients with Atrial Fibrillation Using a Decentralized Platform

NCT06618417

Atrial Fibrillation (AF) Sleep Apnea

RECRUITING NA

Atrial Fibrillation/Sinus Rhythm Before and After Cardioversion

NCT01779674

Atrial Fibrillation

COMPLETED

Predicting Disease Progression in Atrial Fibrillation: A Multiparametric Approach for Prognostic Marker Identification and Personalized Patient Management

NCT06647914

Atrial Fibrillation (AF)

NOT_YET_RECRUITING

PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF

NCT05784077

Atrial Fibrillation Osa Syndrome

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

NightOwl

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No