Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001193662
Ethics application status
Approved
Date submitted
17/10/2023
Date registered
17/11/2023
Date last updated
17/11/2023
Date data sharing statement initially provided
17/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Accuracy of a Novel Sleep Monitoring Technology Compared to Polysomnography in the Intensive Care Unit
Scientific title
Evaluation of the Accuracy of a Novel Sleep Monitoring Technology Compared to Polysomnography in the Intensive Care Unit
Secondary ID [1] 310797 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 331780 0
Condition category
Condition code
Neurological 328519 328519 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327211 0
Treatment: Devices
Comparator / control treatment
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.

Polysomnography is the gold standard for sleep measurement and involves the application of electrodes to the scalp, face and limbs to gather electrical signals for electroencephalography (EEG), electro-oculography (EOG) and electro-myography, in addition to adjunctive cardiorespiratory parameters.

The polysomnography 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) Independent scoring by 2 sleep scientists to determine sleep parameters, including total sleep time and percentage of total sleep time spent in sleep phase subtypes.
Control group
Active

Outcomes
Primary outcome [1] 336344 0
Difference in total sleep time, measured using sleep scientist interpreted polysomnography and automated algorithm scored Somfit data.
Timepoint [1] 336344 0
The 12 hours following commencement of Somfit and polysomnography data collection
Secondary outcome [1] 427928 0
Mean difference in time spend in American Academy of Sleep Medicine sleep phase N1 measured objectively by polysomnography and somfit device.
Timepoint [1] 427928 0
The 12 hours following commencement of Somfit and polysomnography data collection
Secondary outcome [2] 427929 0
Percentage of data loss due to interference or technical issues
Timepoint [2] 427929 0
The 12 hours following commencement of Somfit and polysomnography data collection
Secondary outcome [3] 427930 0
Time lights off (down) and on (up) for the patient sleep period
Timepoint [3] 427930 0
The 12 hours following commencement of Somfit and polysomnography data collection
Secondary outcome [4] 427931 0
Time patient fell asleep and woke up
Timepoint [4] 427931 0
The Sleep Observation Tool will be completed contemporaneously during the 12 hours during Somfit and polysomnography data collection
Secondary outcome [5] 427932 0
Extrinsic activity or disturbances experienced by patient, such as repositioning, procedures, transports
Timepoint [5] 427932 0
Within the 12 hours following commencement of Somfit and polysomnography data collection
Secondary outcome [6] 427933 0
Nursing perception of Somfit and polysomnography devices
Timepoint [6] 427933 0
The usability questionnaire will be completed at the end of the Somfit and polysomnography data collection period.
Secondary outcome [7] 427934 0
Safety of somfit and PSG devices
Timepoint [7] 427934 0
The safety questionnaire will be completed at the end of the Somfit and polysomnography data collection period.
Secondary outcome [8] 428527 0
Mean difference in time spend in American Academy of Sleep Medicine sleep phase N2 measured objectively by polysomnography and somfit device
Timepoint [8] 428527 0
The 12 hours following commencement of Somfit and polysomnography data collection
Secondary outcome [9] 428528 0
Mean difference in time spend in American Academy of Sleep Medicine sleep phase N3 measured objectively by polysomnography and somfit device
Timepoint [9] 428528 0
The 12 hours following commencement of Somfit and polysomnography data collection
Secondary outcome [10] 428529 0
Mean difference in time spend in American Academy of Sleep Medicine sleep phase R measured objectively by polysomnography and Somfit device.
Timepoint [10] 428529 0
The 12 hours following commencement of Somfit and polysomnography data collection.
Secondary outcome [11] 428530 0
Mean difference in time spent with an electroencephalographic waveform that cannot be classified using American Academy of Sleep Medicine sleep scoring criteria measured by polysomnography and Somfit device.
Timepoint [11] 428530 0
The 12 hours following commencement of Somfit and polysomnography data collection

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
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
We will collect a convenience sample of 30 paired recordings and, allowing for a 10% device and recording failure rate, we anticipate this can be achieved by enrolling 33 participants into this pilot trial. This sample size has been informed by 2 prior studies with similar methodologies involving the assessment of the Somfit against polysomnography in the sleep laboratory environment, and of a similar device, the SleepScope, against an under-mattress sleep sensor in the ICU setting. These studies used sample sizes of 30 and 18 participants respectively.

Small pilot studies are, by definition, underpowered to detect many clinically important differences between the observation arms. Thus, the statistical focus of pilot trials should be on descriptive statistics (means, proportions, medians) and their associated standard deviations, confidence intervals or quantile ranges, rather than formal hypothesis testing, to provide an estimate of possible treatment effects. Pilot studies may usefully help assess minimum clinically important differences even if confidence intervals reported are numerically less than 95% (such as 85% or 75%).

Descriptive statistics for the differences in total sleep time (minutes), frequency of arousals (arousals per hour), percentage of total sleep time in N1, N2, N3 and REM sleep (%), and percentage of total sleep period spent awake (%) will be reported.

The primary outcome of total sleep time will be analysed using a Bland Altman plot and quantitative results, including mean biases, standard deviations and 95% confidence intervals of the biases will be reported. In addition, the lower and upper limits of agreement (mean difference +/- 1.96 SD), the 95% confidence intervals of the limits of agreement, and the number of participants falling outside the Bland Altman agreement limits will also be stated.

The intraclass correlation will be calculated to quantify the PSG-Somfit agreement for total sleep time and other sleep outcomes. Intraclass correlation coefficients greater than 0.6-1.0 represent good to excellent agreement.

The secondary outcomes of the percentage of total sleep time spent in N1, N2, N3 and REM, and the percentage of total sleep period (ie. duration of sleep study) awake will also be plotted as Bland Altman plot and reported as stated for the primary outcome.

Secondary outcomes related to the correct determination of sleep phase will be assessed on an epoch-by-epoch basis and will be reported as sensitivity (the percentage of PSG epochs correctly scored as deep sleep by the Somfit device), specificity (percentage of PSG epochs correctly scored as wake by the Somfit device), and agreement (the percentage of all PSG epochs correctly scored as light sleep, deep sleep, REM or wake by the Somfit device). An agreement of greater than 60% would be acceptable for considering the Somfit to warrant further assessment. A Cohen’s kappa will be calculated for each sleep phase and overall performance. The inter-rater reliability for manual sleep scoring of PSG has recently been found to show substantial agreement, with a Cohen’s kappa of 0.76 (95% CI 0.71-0.81, p < 0.01).
All analyses will initially be performed comparing technician-scored PSG to automatically scored Somfit data. Subsequent analyses will compare technician-scored PSG to technician-scored Somfit data, and then technician-scored and automatically scored Somfit data. Adverse outcomes will be presented using descriptive statistics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/11/2023
Actual
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
18/02/2025
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25743 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 41567 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 315036 0
Charities/Societies/Foundations
Name [1] 315036 0
The Australian and New Zealand Intensive Care Foundation
Country [1] 315036 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan Street, Parkville, Victoria 3050
Country
Australia
Secondary sponsor category [1] 317059 0
None
Name [1] 317059 0
Address [1] 317059 0
Country [1] 317059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313997 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 313997 0
Ethics committee country [1] 313997 0
Australia
Date submitted for ethics approval [1] 313997 0
18/04/2023
Approval date [1] 313997 0
20/04/2023
Ethics approval number [1] 313997 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130066 0
Dr Laurie Showler
Address 130066 0
Royal Melbourne Hospital. 300 Grattan Street Parkville, Victoria, 3050
Country 130066 0
Australia
Phone 130066 0
+61 3 93429254
Fax 130066 0
Email 130066 0
[email protected]
Contact person for public queries
Name 130067 0
Brianna Tascone
Address 130067 0
Royal Melbourne Hospital. 300 Grattan Street Parkville, Victoria, 3050
Country 130067 0
Australia
Phone 130067 0
+61 3 9342 9252
Fax 130067 0
Email 130067 0
[email protected]
Contact person for scientific queries
Name 130068 0
Laurie Showler
Address 130068 0
Royal Melbourne Hospital. 300 Grattan Street Parkville, Victoria, 3050
Country 130068 0
Australia
Phone 130068 0
+61 3 93429254
Fax 130068 0
Email 130068 0
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.