NCT04760002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

February 15, 2021

Last Update Submit

March 1, 2023

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Correlation between NightOwl and cardio-respiratory monitoring

    6 months

Study Arms (1)

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

Interventions

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.

Atrial Fibrillation Patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev-Gentofte Hospital

Copenhagen, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34998370DERIVED

Related Links

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate professor, Consultant Cardiology,

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 18, 2021

Study Start

January 25, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)