Evaluation of the Accuracy of a Novel Sleep Monitoring Technology Compared to Polysomnography in the Intensive Care Unit

Not Applicable

• Conditions: Sleep; Neurological - Other neurological disorders

• Registration Number: ACTRN12623001193662
• Lead Sponsor: Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-17
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in total sleep time, measured using sleep scientist interpreted polysomnography and automated algorithm scored Somfit data.[Total sleep time between the manually scored polysomnography data and the algorithmically scored Somfit data The 12 hours following commencement of Somfit and polysomnography data collection]