NCT03866148

Brief Summary

This study is a prevelance trial looking at how sleep apnoea affects the heart especially heart rhythms. Previous research shows that patients suffering from sleep apnoea are much more likely to get heart disease and abnormal heart rhythms (arrhythmias). These defects are sometimes missed by the traditional methods of monitoring i.e. 24-hour Holter monitor and ECGs. This means potentially dangerous arrhythmias may not be detected. Additionally, standard therapy for sleep apnoea does not significantly reduce the risk of heart disease. This study will recruit 200 participants over a period of 18 months. The research team will observe the heart rhythms of sleep apnoea patients by inserting an implantable loop recorder (ILR) in up to 100 participants. The other 100 patients will simply have standard care. This device will monitor the heart continuously for 3 years allowing us to detect abnormal heart rhythms and treat as necessary. Demonstrating the incidence of arrhythmia can lead onto a larger study which may change future sleep apnoea management improving their cardiovascular outcomes. Other markers of heart disease such as; blood tests, Magnetocardiography and Echocardiography will be performed on participants to shed more light on the mechanisms which link sleep apnoea and heart disease/arrhythmia.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

February 13, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 3, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

3.5 years

First QC Date

February 13, 2019

Last Update Submit

June 17, 2024

Conditions

Obstructive Sleep ApneaCardiovascular DiseasesArrhythmiaAtrial Fibrillation New Onset

Keywords

Atrial FibrillationObstructive Sleep ApneaImplantable Loop RecorderExtended Cardiac MonitoringMatrix Metalloproteinase-9Interleukin-6Tumour Necrosis Factor-AlphaHigh sensitivity C-Reactive ProteinHigh sensitivity Troponin-TFibroblast Growth Factor-23Heart Rate VariabilityN-Terminal pro B-type Natriuretic Peptide

Outcome Measures

Primary Outcomes (2)

  • Incidence of arrhythmia

    Incidence of arrhythmia in sleep apnoea patients as recorded by ILR vs a no ILR group

    3 years

  • Autonomic function before and after CPAP

    Assess the changes to the heart in sleep apnoea patients before and after CPAP in terms of heart rate variability as measured on 24 hour holter monitors. The raw data is taken from the monitor and then analysed manually. The first data set will be from baseline studies which will be compared to studies done at the 1 year follow-up.

    3 years

Secondary Outcomes (6)

  • Onset and frequency of atrial fibrillation

    3 years

  • Rate of Cardiovascular Morbidity

    3 years

  • Rate of Cardiovascular Mortality

    3 years

  • Cardiovascular biomarkers before and after CPAP

    3 years

  • Echocardiography before and after CPAP

    3 years

  • +1 more secondary outcomes

Study Arms (2)

ILR

ACTIVE COMPARATOR

Participants who will receive the Implantable Loop Recorder (Reveal-LINQ) inserted just after baseline. This is single intervention and lasts for 3 years after which the patient has the option to have it removed.

Device: Reveal LINQ

No ILR

NO INTERVENTION

Participants who will not get the Implantable Loop Recorder (Reveal-LINQ).

Interventions

Reveal LINQDEVICE

Insertion of monitoring device called Reveal-LINQ (an implantable loop recorder)

ILR

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate to severe sleep apnoea who require CPAP as standard care (AHI \>15)
  • Patients between the age of 18 and 75

You may not qualify if:

  • Patients with a diagnosis of atrial fibrillation (AF), atrial flutter and/or ventricular tachycardia (VT)
  • Patients with an ILR already in-situ or an established indication for ILR
  • Patients with a palliative diagnosis i.e. life expectancy less than 3 years
  • Patients who lack capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Coventry & Warwickshire

Coventry, CV2 2DX, United Kingdom

Location

Related Publications (4)

  • Yeung C, Drew D, Hammond S, Hopman WM, Redfearn D, Simpson C, Abdollah H, Baranchuk A. Extended Cardiac Monitoring in Patients With Severe Sleep Apnea and No History of Atrial Fibrillation (The Reveal XT-SA Study). Am J Cardiol. 2018 Dec 1;122(11):1885-1889. doi: 10.1016/j.amjcard.2018.08.032. Epub 2018 Sep 7.

    PMID: 30274768BACKGROUND

  • McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.

    PMID: 27571048BACKGROUND

  • Javaheri S, Barbe F, Campos-Rodriguez F, Dempsey JA, Khayat R, Javaheri S, Malhotra A, Martinez-Garcia MA, Mehra R, Pack AI, Polotsky VY, Redline S, Somers VK. Sleep Apnea: Types, Mechanisms, and Clinical Cardiovascular Consequences. J Am Coll Cardiol. 2017 Feb 21;69(7):841-858. doi: 10.1016/j.jacc.2016.11.069.

    PMID: 28209226BACKGROUND

  • He H, Lachlan T, Chandan N, Lim VG, Kimani P, Ng GA, Ali A, Randeva H, Osman F. Obstructive Sleep Apnoea and Cardiac Arrhythmias (OSCA) trial: a nested cohort study using injectable loop recorders and Holter monitoring in patients with obstructive sleep apnoea. BMJ Open. 2023 Feb 15;13(2):e070884. doi: 10.1136/bmjopen-2022-070884.

    PMID: 36792325DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveCardiovascular DiseasesArrhythmias, CardiacAtrial Fibrillation

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups with the intervention the difference.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

March 7, 2019

Study Start

October 3, 2019

Primary Completion

April 15, 2023

Study Completion

April 15, 2025

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations

GB(1)