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Trial registered on ANZCTR
Registration number
ACTRN12620000368932
Ethics application status
Approved
Date submitted
25/02/2020
Date registered
17/03/2020
Date last updated
17/03/2020
Date data sharing statement initially provided
17/03/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Diagnosing Sleep Apnoea with Implantable Continuous Monitoring: The Reveal LinQ Sleep Apnoea Algorithm
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Scientific title
Testing the Reveal LinQ (Medtronic) Sleep Apnoea Algorithm: An Initial Feasibility Study
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Secondary ID [1]
300293
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Nil known
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Universal Trial Number (UTN)
U1111-1246-8467
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea
315883
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Condition category
Condition code
Respiratory
314159
314159
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0
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Sleep apnoea
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Cardiovascular
314160
314160
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All participants will be recruited after the implantation of their clinically indicated Reveal LinQ device implantation and prior to their sleep study. The Reveal LinQ implant will be undertaken by a qualified Cardiologist or training Cardiologist (at least 5 years training post-qualification) in a cardiac catheter laboratory. The implantable device is small (measuring 44.8 x 7.2 x 4 mm and weighing 2.5g) and can be implanted under local anaesthetic with no requirement for general anaesthetic or sedation. The device is implanted under the skin in the left parasternal region.
Participants will then undergo overnight laboratory-based polysomnography with scoring using standard criteria. At the same time, they will be attached to a Medtronic Holter monitor capable of continuously extracting the LinQ electrograms in real-time. In many cases, for example patients with AF, this will be a clinically indicated procedure.
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Intervention code [1]
316567
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Diagnosis of obstructive sleep apnoea based on a variety of algorithms using data extracted from implantable Medtronic LinQ device.
The algorithms will be retrospectively evaluated against the gold standard of the simultaneously undertaken polysomnography..
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Assessment method [1]
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Timepoint [1]
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Immediately following sleep study.
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Secondary outcome [1]
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Apnoeic and hypopnoeic episodes - these will be assessed using both polysomnography and the LinQ device algorithm. Specifically, apnoeic and hypopnoeic episodes are determined by combining information from at least 12 channels of data including electroencephalogram (EEG), electrooculogram (EOG), electromyogram (EMG), oronasal airflow, chest wall effort, body position, snore microphone, ECG, and oxyhemoglobin saturation.
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Assessment method [1]
378890
0
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Timepoint [1]
378890
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At time of overnight polysomnography
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Secondary outcome [2]
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Apnoea-hypopnoea index (AHI) – defined as the number of apnoea or hypopnoea events per hour of sleep assessed by polysomnography and the LinQ device algorithm.
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Assessment method [2]
378891
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Timepoint [2]
378891
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At time of overnight polysomnography
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Secondary outcome [3]
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Total sleep time - assessed by polysomnography and the LinQ device algorithm.
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Assessment method [3]
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Timepoint [3]
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At time of overnight polysomnography
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Secondary outcome [4]
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Time spent in each sleep stage - assessed by polysomnography and the LinQ device algorithm.
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Assessment method [4]
378893
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Timepoint [4]
378893
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At time of overnight polysomnography
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Secondary outcome [5]
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Mean sleep efficiency - assessed by polysomnography and the LinQ device algorithm.
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Assessment method [5]
378894
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Timepoint [5]
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At time of overnight polysomnography
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Secondary outcome [6]
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Mean sleep latency - assessed by polysomnography and the LinQ device algorithm.
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Assessment method [6]
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Timepoint [6]
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At time of overnight polysomnography
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Secondary outcome [7]
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Heart rate variability - assessed by polysomnography and the LinQ device algorithm.
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Assessment method [7]
378897
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Timepoint [7]
378897
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At time of overnight polysomnography
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Secondary outcome [8]
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Overnight heart rhythm - assessed by polysomnography and the LinQ device algorithm.
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Assessment method [8]
378898
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Timepoint [8]
378898
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At time of overnight polysomnography
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Secondary outcome [9]
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Mean heart rate - assessed by polysomnography and the LinQ device algorithm.
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Assessment method [9]
378899
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Timepoint [9]
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At time of overnight polysomnography
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Eligibility
Key inclusion criteria
This study will recruit patients with an implantable Medtronic LinQ device for clinically indicated reasons
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Contraindication to intracardiac monitor implantation
2. Contraindication to undergoing overnight sleep study
3. Inability to provide informed consent
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
7/04/2020
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Actual
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Date of last participant enrolment
Anticipated
1/07/2020
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
29031
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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In-Kind support from Centre for Heart Rhythm Disorders, University of Adelaide
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Address [1]
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University of Adelaide,
Adelaide,
SA, 5005
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Country [1]
305049
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Australia
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Primary sponsor type
University
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Name
University of Adelaide
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Address
University of Adelaide,
Adelaide,
SA, 5005
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
305413
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Country [1]
305413
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Central Adelaide Local Health Network Human Research Ethics Committee
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Ethics committee address [1]
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Royal Adelaide Hospital Clinical Trial Centre Level 3, Wayfinder 3D460.02 Port Road ADELAIDE SA 5000
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Ethics committee country [1]
305142
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Australia
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Date submitted for ethics approval [1]
305142
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Approval date [1]
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19/12/2019
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Ethics approval number [1]
305142
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Summary
Brief summary
Obstructive sleep apnoea (OSA) increases the risk of atrial fibrillation in a dose-dependent manner. There is growing evidence to suggest that early diagnosis and aggressive management of OSA with continuous positive airway pressure (CPAP) can reduce the symptoms and improve the long-term outcomes associated with atrial fibrillation. However, diagnosis of sleep apnoea is difficult, requiring admission to hospital for intensive overnight monitoring (polysomnography). Furthermore, there is evidence to suggest that single assessment during just one night is insufficient to make an accurate diagnosis. New generation implantable cardiac devices offer new hope for detection of respiratory disturbance during sleep, allowing for continuous monitoring of respiratory disturbance from home over periods of weeks rather than hours. Medtronic, in conjunction with the Principle Investigator, have developed a variety of algorithms for the diagnosis of obstructive sleep apnoea using the implantable Medtronic LinQ device. Diagnosis is based on monitoring of ventilation by means of thoracic impedance changes between the device case and electrode tip. This study will assess the ability of these device-based algorithms to detect obstructive sleep apnoea through comparison with gold-standard polysomnography results. Patients with clinically indicated Medtronic LinQ Recorder implants will be recruited and will subsequently undergo overnight polysomnography. A Holter monitor capable of collecting electrograms directly from the Reveal LinQ device will be used during polysomnography. Medtronic algorithm data from the Reveal LinQ device will then be compared with polysomnography data to validate the use of the Medtronic algorithm to diagnose sleep apnoea.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Prash Sanders
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Address
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Director, Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
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Country
99382
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Australia
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Phone
99382
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+61 883139000
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Fax
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Email
99382
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[email protected]
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Contact person for public queries
Name
99383
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Ellen Lyrtzis
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Address
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South Australian Health and Medical Research Institute
PO Box 11060
Adelaide 5001
South Australia
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Country
99383
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Australia
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Phone
99383
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+61 8 8128 4000
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Fax
99383
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Email
99383
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[email protected]
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Contact person for scientific queries
Name
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Prash Sanders
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Address
99384
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Director, Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
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Country
99384
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Australia
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Phone
99384
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+61 883139000
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Fax
99384
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Email
99384
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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