None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Adelaide
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
This study will recruit patients with an implantable Medtronic LinQ device for clinically indicated reasons
Exclusion criteria
1. Contraindication to intracardiac monitor implantation 2. Contraindication to undergoing overnight sleep study 3. Inability to provide informed consent
Outcome results
None listed