None listed
Conditions
Brief summary
Each year 160,000 critically ill Australians are admitted to an Intensive Care Unit (ICU) to receive life-saving treatments and around-the-clock care. There is concern that sleep disturbances may result in worse outcomes, including confusion, memory impairment, and depression, some of which may persist for months after leaving the ICU. There are numerous barriers to monitoring the quality and quantity of sleep in ICU patients, with the gold-standard technique of polysomnography (PSG) posing substantial technical and logistical challenges. A new, wearable device, the Somfit (Compumedics) that uses a smartphone app and computer analysis to measure sleep may provide a simpler alternative. This study will compare this novel device and automated scoring algorithm to polysomnography (PSG) interpreted by a trained sleep technologist in adult patients in the ICU.
Interventions
Participants will have a Somfit sleep monitoring device (intervention) and full polysomnography (control) applied for a one-off, 14-hour period between 18:00 and 08:00. Both devices will be applied by a Sleep Technologist or other trained personnel.
The Somfit is a wearable sleep-tracking device developed by Compumedics. It consists of a reusable, plastic-encased device and single use adhesive electrode that is applied to the forehead. The Somfit can perform 2-channel electroencephalography, e
Participants will have a Somfit sleep monitoring device (intervention) and full polysomnography (control) applied for a one-off, 14-hour period between 18:00 and 08:00. Both devices will be applied by a Sleep Technologist or other trained personnel. The Somfit is a wearable sleep-tracking device developed by Compumedics. It consists of a reusable, plastic-encased device and single use adhesive electrode that is applied to the forehead. The Somfit can perform 2-channel electroencephalography, encephalooculography, electromyography, transcutaneous pulse oximetry, monitor ambient light and noise, and detect motion. The acquired data is transferred via Bluetooth to a dedicated smartphone application, where it can be transmitted to a secure cloud-based platform and interpreted using a proprietary automated scoring algorithm. The Somfit data will undergo the following processes: 1) Review by a sleep scientist for integrity to identify any periods of loss of signal acquisition and interference. 2) Initial scoring of using Compumedic's proprietary sleep scoring algorithm to determine sleep parameters, including total sleep time and percentage of total sleep time spent in sleep phase subtypes. 3) Subsequent scoring by a sleep scientist to allow comparison with results obtained using the proprietary sleep scoring algorithm.
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 18 years and over • Expected ICU length of stay > 24 hours • Richmond Agitation Scale Score (RASS) between -2 to 0 - RASS score should be stable within these limits for the 2 hours preceding enrolment. - Any divergence outside these parameters occurring between enrolment and application of the study devices should be discussed with the principal investigator to determine suitability to proceed.
Exclusion criteria
• Suspected or confirmed diagnosis of acute central nervous system pathology • Acute head and neck injury or surgery • Acute psychiatric or behavioural disturbance • Acute toxic ingestion • History of seizures • Continuous infusions of propofol or benzodiazepines • Position restrictions that may limit the application of monitoring devices • The treating Intensivist’s perception that devices will be poorly tolerated by the patient for the study period • Previous enrolment in this study
Outcome results
None listed