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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
Scientific title
Testing the Reveal LinQ (Medtronic) Sleep Apnoea Algorithm: An Initial Feasibility Study
Secondary ID [1] 300293 0
Nil known
Universal Trial Number (UTN)
U1111-1246-8467
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 315883 0
Condition category
Condition code
Respiratory 314159 314159 0 0
Sleep apnoea
Cardiovascular 314160 314160 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 316567 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322544 0
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..
Timepoint [1] 322544 0
Immediately following sleep study.
Secondary outcome [1] 378890 0
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.
Timepoint [1] 378890 0
At time of overnight polysomnography
Secondary outcome [2] 378891 0
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.
Timepoint [2] 378891 0
At time of overnight polysomnography
Secondary outcome [3] 378892 0
Total sleep time - assessed by polysomnography and the LinQ device algorithm.
Timepoint [3] 378892 0
At time of overnight polysomnography
Secondary outcome [4] 378893 0
Time spent in each sleep stage - assessed by polysomnography and the LinQ device algorithm.
Timepoint [4] 378893 0
At time of overnight polysomnography
Secondary outcome [5] 378894 0
Mean sleep efficiency - assessed by polysomnography and the LinQ device algorithm.
Timepoint [5] 378894 0
At time of overnight polysomnography
Secondary outcome [6] 378896 0
Mean sleep latency - assessed by polysomnography and the LinQ device algorithm.
Timepoint [6] 378896 0
At time of overnight polysomnography
Secondary outcome [7] 378897 0
Heart rate variability - assessed by polysomnography and the LinQ device algorithm.
Timepoint [7] 378897 0
At time of overnight polysomnography
Secondary outcome [8] 378898 0
Overnight heart rhythm - assessed by polysomnography and the LinQ device algorithm.
Timepoint [8] 378898 0
At time of overnight polysomnography
Secondary outcome [9] 378899 0
Mean heart rate - assessed by polysomnography and the LinQ device algorithm.
Timepoint [9] 378899 0
At time of overnight polysomnography

Eligibility
Key inclusion criteria
This study will recruit patients with an implantable Medtronic LinQ device for clinically indicated reasons

Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindication to intracardiac monitor implantation
2. Contraindication to undergoing overnight sleep study
3. Inability to provide informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15628 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 29031 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 305049 0
University
Name [1] 305049 0
In-Kind support from Centre for Heart Rhythm Disorders, University of Adelaide
Address [1] 305049 0
University of Adelaide,
Adelaide,
SA, 5005
Country [1] 305049 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
University of Adelaide,
Adelaide,
SA, 5005
Country
Australia
Secondary sponsor category [1] 305413 0
None
Name [1] 305413 0
Address [1] 305413 0
Country [1] 305413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305142 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 305142 0
Royal Adelaide Hospital
Clinical Trial Centre
Level 3, Wayfinder 3D460.02
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 305142 0
Australia
Date submitted for ethics approval [1] 305142 0
Approval date [1] 305142 0
19/12/2019
Ethics approval number [1] 305142 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99382 0
Prof Prash Sanders
Address 99382 0
Director, Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 99382 0
Australia
Phone 99382 0
+61 883139000
Fax 99382 0
Email 99382 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 99383 0
Miss Ellen Lyrtzis
Address 99383 0
South Australian Health and Medical Research Institute
PO Box 11060
Adelaide 5001
South Australia
Country 99383 0
Australia
Phone 99383 0
+61 8 8128 4000
Fax 99383 0
Email 99383 0
ellen.lyrtzis@adelaide.edu.au
Contact person for scientific queries
Name 99384 0
Prof Prash Sanders
Address 99384 0
Director, Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 99384 0
Australia
Phone 99384 0
+61 883139000
Fax 99384 0
Email 99384 0
prash.sanders@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results