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Obstructive Sleep Apnoea and Cardiac Arrhythmias (OSCA)

Primary Purpose

Obstructive Sleep Apnea, Cardiovascular Diseases, Arrhythmia

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Reveal LINQ
Sponsored by
University Hospitals Coventry and Warwickshire NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Atrial Fibrillation, Obstructive Sleep Apnea, Implantable Loop Recorder, Extended Cardiac Monitoring, Matrix Metalloproteinase-9, Interleukin-6, Tumour Necrosis Factor-Alpha, High sensitivity C-Reactive Protein, High sensitivity Troponin-T, Fibroblast Growth Factor-23, Heart Rate Variability, N-Terminal pro B-type Natriuretic Peptide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital Coventry & Warwickshire

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ILR

No ILR

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Onset and frequency of atrial fibrillation
Explore the onset and frequency of atrial fibrillation in sleep apnoea patients in order to determine what method of detection is efficient and cost effective.
Rate of Cardiovascular Morbidity
Explore the impact of inserting an ILR in patients with sleep apnoea on cardiovascular morbidity (stroke and myocardial infarction) compared to those without ILR
Rate of Cardiovascular Mortality
Explore the impact of inserting an ILR in patients with sleep apnoea on cardiovascular mortality (stroke and/or myocardial infarction resulting in death) compared to those without ILR
Cardiovascular biomarkers before and after CPAP
Explore the changes to the heart in sleep apnoea patients before and after CPAP in terms of vascular biomarkers - high sensitivity C-Reactive Protein, high sensitivity Troponin-T, N-terminal pro B-type Natriuretic Peptide, Tumour Necrosis Factor-alpha, Matrix Metalloproteinase-9, Interleukin-6, Fibroblast Growth Factor-23. The first data set will be from baseline studies which will be compared to studies done at the 1 year follow-up.
Echocardiography before and after CPAP
Explore the changes to the heart in sleep apnoea patients before and after CPAP in terms of echocardiogram measures.
Quality of life: EQ-5D-5L questionnaire
Quality of life measures before and after CPAP as measured by the EQ-5D 5 level questionnaire. This measures various quality of life points from a scale of 1-5. 1 represents poor quality of life and 5 represents good quality of life for each factor. This data will be analysed as per the EuroQol algorithm. The first data set will be from baseline studies which will be compared to studies done at the 1 year follow-up.

Full Information

First Posted
February 13, 2019
Last Updated
May 31, 2023
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03866148
Brief Title
Obstructive Sleep Apnoea and Cardiac Arrhythmias
Acronym
OSCA
Official Title
Obstructive Sleep Apnoea and Cardiac Arrhythmias and the Impact of an Implantable Loop Recorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Coventry and Warwickshire NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Sleep apnoea affects up to 1.5 million adults in the United Kingdom (UK). This puts this population at risk of reduced oxygen levels during sleep, poor sleep and increased breathing effort . All of the above put stress on the body and are proven to increase the risk of high blood pressure, heart failure and vascular problems. This can lead to strokes, heart disease and death. Sleep apnoea patients are at much higher risk of abnormal heart rhythms. Even with continuous positive airways pressure (CPAP) treatment (which is the mainstay in sleep apnoea and does help to reduce arrhythmias) patients are still at higher risk of heart disease and stroke. An implantable loop recorder (Reveal-LINQ) inserted into sleep apnoea patients will be able to continuously monitor a patient's heart rhythm. This will determine the incidence of arrhythmia in sleep apnoea patients. Any significant abnormalities in either arm of the study will be treated as per National Health Service guidelines and best care. The cost associated with this method of intervention will also be considered. If there is a high prevalence of arrhythmia a future larger trial, involving much larger numbers and multiple centres, could be conducted to demonstrate reduced risk of stroke or heart attack using this method of arrhythmia detection and management. Cardiovascular biomarkers, cardiac function, autonomic function and magnetocardiography in these patients could shed light on the mechanisms which cause increased cardiovascular morbidity and mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Cardiovascular Diseases, Arrhythmia, Atrial Fibrillation New Onset
Keywords
Atrial Fibrillation, Obstructive Sleep Apnea, Implantable Loop Recorder, Extended Cardiac Monitoring, Matrix Metalloproteinase-9, Interleukin-6, Tumour Necrosis Factor-Alpha, High sensitivity C-Reactive Protein, High sensitivity Troponin-T, Fibroblast Growth Factor-23, Heart Rate Variability, N-Terminal pro B-type Natriuretic Peptide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups with the intervention the difference.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ILR
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No ILR
Arm Type
No Intervention
Arm Description
Participants who will not get the Implantable Loop Recorder (Reveal-LINQ).
Intervention Type
Device
Intervention Name(s)
Reveal LINQ
Intervention Description
Insertion of monitoring device called Reveal-LINQ (an implantable loop recorder)
Primary Outcome Measure Information:
Title
Incidence of arrhythmia
Description
Incidence of arrhythmia in sleep apnoea patients as recorded by ILR vs a no ILR group
Time Frame
3 years
Title
Autonomic function before and after CPAP
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Onset and frequency of atrial fibrillation
Description
Explore the onset and frequency of atrial fibrillation in sleep apnoea patients in order to determine what method of detection is efficient and cost effective.
Time Frame
3 years
Title
Rate of Cardiovascular Morbidity
Description
Explore the impact of inserting an ILR in patients with sleep apnoea on cardiovascular morbidity (stroke and myocardial infarction) compared to those without ILR
Time Frame
3 years
Title
Rate of Cardiovascular Mortality
Description
Explore the impact of inserting an ILR in patients with sleep apnoea on cardiovascular mortality (stroke and/or myocardial infarction resulting in death) compared to those without ILR
Time Frame
3 years
Title
Cardiovascular biomarkers before and after CPAP
Description
Explore the changes to the heart in sleep apnoea patients before and after CPAP in terms of vascular biomarkers - high sensitivity C-Reactive Protein, high sensitivity Troponin-T, N-terminal pro B-type Natriuretic Peptide, Tumour Necrosis Factor-alpha, Matrix Metalloproteinase-9, Interleukin-6, Fibroblast Growth Factor-23. The first data set will be from baseline studies which will be compared to studies done at the 1 year follow-up.
Time Frame
3 years
Title
Echocardiography before and after CPAP
Description
Explore the changes to the heart in sleep apnoea patients before and after CPAP in terms of echocardiogram measures.
Time Frame
3 years
Title
Quality of life: EQ-5D-5L questionnaire
Description
Quality of life measures before and after CPAP as measured by the EQ-5D 5 level questionnaire. This measures various quality of life points from a scale of 1-5. 1 represents poor quality of life and 5 represents good quality of life for each factor. This data will be analysed as per the EuroQol algorithm. The first data set will be from baseline studies which will be compared to studies done at the 1 year follow-up.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with moderate to severe sleep apnoea who require CPAP as standard care (AHI >15) Patients between the age of 18 and 75 Exclusion Criteria: 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
Facility Information:
Facility Name
University Hospital Coventry & Warwickshire
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30274768
Citation
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.
Results Reference
background
PubMed Identifier
27571048
Citation
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.
Results Reference
background
PubMed Identifier
28209226
Citation
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.
Results Reference
background

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Obstructive Sleep Apnoea and Cardiac Arrhythmias

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