None listed
Conditions
Brief summary
This study will compare the effects of simplified sleep study testing (with fewer monitoring channels than usual) versus full sleep studies for the diagnosis of obstructive sleep apnea (OSA), by investigating the accuracy of 3 different simplified sleep study devices, their impacts on physician decision-making and important patient outcomes (including symptoms of daytime sleepiness) and whether the use of simplified testing devices in the management of OSA is associated with significant cost savings. The study hypothesis is that limited-channel sleep study testing is accurate, effective and cost-effective compared to full sleep study testing in the diagnosis and management of patients with suspected OSA.
Interventions
Patients will be randomly assigned to one of four study arms (1:1:1:1) for diagnostic sleep study evaluation. The 4 arms will consist of a control arm (home or laboratory PSG) and 3 different type 3 or 4 (limited-channel) sleep study devices.
ARM 1: Nox T3 (Nox Medical), a traditional type 3 device which measures thoracic and abdominal respiratory inductance plethysmography (RIP), nasal pressure, snore signal, oximetry and pulse.
ARM 2: Watch-PAT 1M (ZOLL Itamar), a peripheral arterial tonometry
Patients will be randomly assigned to one of four study arms (1:1:1:1) for diagnostic sleep study evaluation. The 4 arms will consist of a control arm (home or laboratory PSG) and 3 different type 3 or 4 (limited-channel) sleep study devices. ARM 1: Nox T3 (Nox Medical), a traditional type 3 device which measures thoracic and abdominal respiratory inductance plethysmography (RIP), nasal pressure, snore signal, oximetry and pulse. ARM 2: Watch-PAT 1M (ZOLL Itamar), a peripheral arterial tonometry (PAT) device which records a PAT signal, heart rate, oximetry, body position, snoring and chest motion via 3 points of contact (i.e., chest sensor, wristband device and finger probe) and utilises a smartphone app to transmit sleep study data to the cloud. ARM 3: Somfit (Compumedics Ltd), a novel device which consists of a sensor worn on the forehead that measures EEG, EOG and EMG, pulse oximetry and PAT signal, and transmits data to a smartphone app via Bluetooth. Participants in type 3/4 intervention arms will use their allocated limited-channel device for 3 consecutive nights to assess the impacts of night-to-night variability and potential benefit of undertaking multi-night recordings compared to single-night testing. On night 1, all patients allocated to type 3/4 study arms will undergo simultaneous testing with full PSG (i.e., type 1 or 2) and their allocated simplified study device. On nights 2 and 3, patients in type 3/4 arms will continue to use the same limited-channel study device on its own at home. At the post-test follow-up visit, sleep physicians will be given a sleep study report and access to raw data corresponding to their patient’s randomised study arm. For patients in type 3/4 intervention arms, physicians will be given a report generated using auto-scored data from their relevant device recorded on night 1 (single night), access to routinely-available raw data, and will be blinded to PSG data. Sleep physicians will use the sleep study information as a basis for further diagnostic and management decisions, and OSA treatments will be recommended at their discretion, as per usual clinical practice.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Referral to sleep specialist for assessment of suspected OSA 2) Aged 18 years or over 3) Fulfil criteria for home sleep study testing
Exclusion criteria
1) Previous sleep study and/or diagnosis of and/or treatment for OSA in the past 5 years 2) Referral for non-respiratory sleep disorder 3) Severe psychiatric disorder or cognitive impairment that will affect ability of the subject to provide informed consent or comply with the study protocol 4) Neuromuscular disease, severe chronic obstructive (FEV1/FVC <70% and FEV1 <50% predicted) or restrictive (TLC <50% predicted) pulmonary disease, respiratory failure from any cause, and/or require supplemental oxygen 5) Unstable cardiovascular (CV) disease or cardiac failure (i.e., hospitalisation for CV event in previous 3 months or New York Heart Association categories III-IV)
Outcome results
None listed