Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000854730
Ethics application status
Approved
Date submitted
30/05/2022
Date registered
17/06/2022
Date last updated
25/04/2024
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of a single forehead sensor against polysomnography and evaluation of the introduction of a circadian lighting solution on sleep, circadian rhythms and recovery in the intensive care unit (ICU)
Scientific title
Validation of a single forehead sensor against polysomnography and evaluation of the introduction of a circadian lighting solution on sleep, circadian rhythms and recovery in the ICU
Secondary ID [1] 307247 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep deprivation in ICU 326495 0
Circadian rhythm disturbance in ICU 326496 0
Delirium 326497 0
Condition category
Condition code
Public Health 323759 323759 0 0
Health service research
Mental Health 323760 323760 0 0
Other mental health disorders
Neurological 323867 323867 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We plan to consent and then recruit a feasibility sample of 30 patients to this study. All suitable patients will be approached to participate in the study and provide consent for the study evaluations. Consented patients will undergo objective sleep evaluation via formal sleep studies and validated questionnaires, and measurements of their circadian rhythms via blood tests and analysis of routinely collected physiological measurements such as core temperature, blood pressure and heart rate. All consenting patients will be assessed for delirium as part of routine patient screening in the ICU, and the data will be compared to evaluate whether there are any differences in sleep patterns / quality, circadian rhythms and recovery between delirious and non-delirious patients. A complete evaluation of the lighting conditions of the bedspace will be conducted, as well as measurements of sound and alarm levels. We will also evaluate patients’ self-reported quality of life, sleep and function 6 months after ICU discharge.

The only intervention component of the study is the upgrade / rebuilding of two ICU bedspaces to improve the physical and sensory environments, including the installation of circadian lighting solutions.

Study plan:

1. Sleep evaluation:

Sleep evaluation will be performed in multiple ways.
1. Single forehead sensor electroencephalogram (EEG)
2. Polysomnography
3. Validated sleep questionnaires

1.1. Single forehead sensor EEG:
Sleep will be measured continuously for the study period (for minimum of 2 days up to maximum 4 days (determined by whether they are still in ICU) following recruitment to the study) using a single forehead sensor EEG. This is a recently developed wearable device that is light and comfortable for patients to wear while enabling collection of high-quality EEG signals, and will be worn continuously for the duration of data collection (up to 4 days post-enrolment). The sensor will be administered by a trained university honours student supervised by a trained expert sleep scientist.

1.2. Polysomnography:
Polysomnography (PSG) is the gold standard for sleep monitoring. Sleep will be concurrently measured using a portable Somtê polysomnography recorder for a 24-hour period between day 2 and 4 after recruitment to participate. The Somtê is a small, portable PSG that is worn as a belt across the patient’s thorax. Ten sensors are attached to the patient: 2 under the chin, 1 next to each eye, and 6 on the scalp. The sensors will measure and monitor muscle tone changes using electromyogram (EMG), eye movements using electroocculogram (EOG) and electrical activity in the brain using electroencephalogram (EEG). The EEG sensors will be attached to the patient’s skin using conductive electrode paste. The equipment also has an inbuilt oximeter to measure pulse oximetry and can also measure patient body position as well as background light and sound. The equipment also collects ECG, leg EMG, nasal pressure/thermistor and ribcage / abdominal movements. The PSG will be administered by a trained university honours student supervised by a trained expert sleep scientist.

1.3. Other / demographic data collection:
Demographics and other relevant data will be collected and analysed against sleep quality/quantity as well as circadian rhythm disturbances (see below).

1.4. Sleep evaluation data and statistical analysis:
Data collected via PSG and the single forehead sensor will be analysed in two ways. 1) The data will be analysed and interpreted by expert sleep scientists, which is the gold standard for sleep study interpretation. 2) The quality and quantity of sleep will also automatically be analysed and interpreted using the company automatic sleep staging algorithm.

Manually analysed PSG data (gold standard) will be validated against manually analysed single forehead sensor data. Environmental noise and light, and nursing interventions, will be linked to sleep data where able to analyse reasons for disrupted sleep.

Patients with delirium will be analysed and compared to patients without delirium. Delirium will be assessed twice daily during the study period using CAM-ICU (routinely collected in ICU).

2. Circadian rhythms:
Data will be collected from environmental sensors, study records, participants, medical records and routinely collected biological samples. The following parameters will be analysed to evaluate the circadian synchronisation of the patients and study their influence on the outcome of the patients:

2.1. Continuous physiological data (routinely monitored):
Body temperature, heart rate and heart rate variability, blood pressure, enteral feeding rhythm.

2.2. Sleep:
As listed above.

2.3. Blood:
2 ml of blood will be collected from participating patients every 4 hours via their arterial line for a 24-hour study period. Cortisol, melatonin and IGF1 levels will be analysed, as well as untargeted RNA-sequencing and proteomics analysis, and lastly expression of circadian clock genes in white blood cells, which will allow the evaluation of the impact of the ICU environment on the global circadian rhythmicity of the patients.

3. Light quality and quantity:

We are comparing 3 lighting environments available within a single ICU, with access to:
• Room 1: Natural light and standard artificial light (standard window-facing bedspace)
• Room 2: Standard artificial light (standard non-window facing bedspace)
• Room 3: Novel artificial circadian light (redesigned non-window facing bedspace).

The standard artificial light is a traditional ceiling light that is either on or off, controlled by the clinician, and no ability to vary or modify the intensity or colour temperature of the light. This will be controlled by the bedside clinician as per standard practice. The circadian lighting solution is a tuned and controlled light that will mimic natural daylight, with the intensity and colour temperature changing in a pre-set manner to imitate the outdoor lighting conditions. This will be fully automated, but the clinicians have the ability to over-ride the pre-programmed lighting should this be required for optimal clinical care.

Patients will be admitted to an ICU bedspace (room type) as per standard unit admission and bedspace allocation, and suitable patients approached to participate in the study. A small number of participants may move between different types of bedspaces / room types depending on the clinical requirements and patient flow of the ICU at the time. We will follow-up the participants for the 4 day study period regardless of whether they move bedspaces or not.
Intervention code [1] 323684 0
Treatment: Other
Comparator / control treatment
The only control is traditional (unmodified) ICU bedspaces, including standard ICU lighting (standard artificial light +/- natural light via windows).
Control group
Active

Outcomes
Primary outcome [1] 331524 0
Maintenance of circadian rhythms between improved and unmodified ICU bedspaces. Circadian rhythms will be assessed by 1) analysis of routinely monitored physiological data collected via the bedside patient monitor and downloaded from the electronic medical records (body temperature, heart rate, heart rate variability and blood pressure), 2) sleep (via PSG), 3) blood tests every 4 hours (cortisol, melatonin, IGF1 levels, untargeted RNA-sequencing, proteomics analysis, and expression of circadian clock genes in white blood cells).
Timepoint [1] 331524 0
For a 24 hour period between day 2 and 4 after recruitment to participate.
Secondary outcome [1] 410169 0
Quality of sleep for patients in the ICU using PSG, single forehead sensor EEG and the sleep in the ICU questionnaire.
Timepoint [1] 410169 0
Sleep will be measured continuously for the study period (for minimum of 2 days up to maximum 4 days (determined by whether they are still in ICU) following recruitment to the study).
Secondary outcome [2] 410170 0
Comparison of patient sleep quality before versus after environmental modifications / upgrades using PSG, single forehead sensor EEG and the sleep in the ICU questionnaire.
Timepoint [2] 410170 0
Sleep will be measured continuously for the study period (for minimum of 2 days up to maximum 4 days (determined by whether they are still in ICU) following recruitment to the study).
Secondary outcome [3] 410171 0
Validate a single forehead sensor EEG against the gold standard PSG for evaluating sleep quality of patients admitted to the ICU.
Timepoint [3] 410171 0
Sleep will be measured continuously for the study period (for minimum of 2 days up to maximum 4 days (determined by whether they are still in ICU) following recruitment to the study).
Secondary outcome [4] 410173 0
Evaluate the effect of introducing a circadian lighting system into a windowless ICU bedspace on the composite quality and quantity of light. The quality/quantity of light in these bedspaces will be measured by photometric measures over a 48-hour period. Measurements will include indoor vertical and horizontal illuminance (photopic and melanopic), luminance, and reflectance values at both room and patient (bed) level. Measures will be collected with unobtrusive, validated, and calibrated instruments.
Timepoint [4] 410173 0
Continuously over a 24 hour period after introducing the circadian lighting solution.
Secondary outcome [5] 410174 0
Evaluate the effect of introducing a circadian lighting system into a windowless ICU bedspace on patient circadian rhythms. Circadian rhythms will be assessed by 1) analysis of routinely monitored physiological data collected via the bedside patient monitor and downloaded from the electronic medical records (body temperature, heart rate, heart rate variability and blood pressure), 2) sleep (via PSG), 3) blood tests every 4 hours (cortisol, melatonin, IGF1 levels, untargeted RNA-sequencing, proteomics analysis, and expression of circadian clock genes in white blood cells).
Timepoint [5] 410174 0
For a 24 hour period between day 2 and 4 after recruitment to participate.
Secondary outcome [6] 410175 0
Evaluate the long-term impact of sleep deprivation in ICU. We will use validated self-report questionnaires to evaluate patient recovery encompassing three functional domains: (physical, cognitive and psychological): The Short Form Survey 36 (SF36v2), The PROMIS Applied Cognition-Abilities Scale (PROMIS), The Hospital Anxiety and Depression Scale (HADS), The Trauma Screening Questionnaire (TSQ), The EQ-5D-5L and ongoing sleep quality and quantity using the Somfit device to collect physiological data, which is worn on the patient’s forehead using a single-use adhesive-gel electrode. It is paired to a mobile phone which transmits data via Bluetooth. We will also ask the patient to complete the validated Pittsburgh Sleep Quality Index (PSQI).
Timepoint [6] 410175 0
6 month after ICU discharge.
Secondary outcome [7] 410176 0
Evaluate the long-term impact of loss of circadian rhythms in ICU. We will use validated self-report questionnaires to evaluate patient recovery encompassing three functional domains: (physical, cognitive and psychological): The Short Form Survey 36 (SF36v2), The PROMIS Applied Cognition-Abilities Scale (PROMIS), The Hospital Anxiety and Depression Scale (HADS), The Trauma Screening Questionnaire (TSQ), The EQ-5D-5L and ongoing sleep quality and quantity using the Somfit device to collect physiological data, which is worn on the patient’s forehead using a single-use adhesive-gel electrode. It is paired to a mobile phone which transmits data via Bluetooth. We will also ask the patient to complete the validated Pittsburgh Sleep Quality Index (PSQI).
Timepoint [7] 410176 0
6 month after ICU discharge. The Somfit device will be used for 1 day at 6 month after ICU discharge.
Secondary outcome [8] 410177 0
Compare the quality of sleep (using PSG, single forehead sensor EEG and the sleep in the ICU questionnaire) for patients diagnosed with delirium during the period of study versus patients who did not have delirium in the study period.
Timepoint [8] 410177 0
Sleep will be measured continuously for the study period (for minimum of 2 days up to maximum 4 days (determined by whether they are still in ICU) following recruitment to the study).
Secondary outcome [9] 410751 0
Quantity of sleep for patients in the ICU using PSG, single forehead sensor EEG and the sleep in the ICU questionnaire.
Timepoint [9] 410751 0
Sleep will be measured continuously for the study period (for minimum of 2 days up to maximum 4 days (determined by whether they are still in ICU) following recruitment to the study).
Secondary outcome [10] 410752 0
Comparison of patient sleep quantity before versus after environmental modifications / upgrades using PSG, single forehead sensor EEG and the sleep in the ICU questionnaire.
Timepoint [10] 410752 0
Sleep will be measured continuously for the study period (for minimum of 2 days up to maximum 4 days (determined by whether they are still in ICU) following recruitment to the study).
Secondary outcome [11] 410753 0
Validate a single forehead sensor EEG against the gold standard PSG for evaluating sleep quantity of patients admitted to the ICU.
Timepoint [11] 410753 0
Sleep will be measured continuously for the study period (for minimum of 2 days up to maximum 4 days (determined by whether they are still in ICU) following recruitment to the study).
Secondary outcome [12] 410755 0
Compare the quantity of sleep (using PSG, single forehead sensor EEG and the sleep in the ICU questionnaire) for patients diagnosed with delirium during the period of study versus patients who did not have delirium in the study period.
Timepoint [12] 410755 0
Sleep will be measured continuously for the study period (for minimum of 2 days up to maximum 4 days (determined by whether they are still in ICU) following recruitment to the study).

Eligibility
Key inclusion criteria
• Adult patients (age greater than or equal to 18 years)
• Written informed consent by patient or legally authorised person
• ICU length of stay >2 days at time of recruitment to participate and expected to remain in ICU for a minimum of 2-3 further days
• Arterial or central venous line in situ to allow blood tests to be collected
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age <18 years
• Unable or unwilling to provide consent to participate
• Deeply and moderately sedated patients (RASS score -3, -4 or -5)
• General anaesthetic, drug overdose or alcohol intoxication in the preceding 24 hours
• Recent substantial neurological insult (e.g. stroke)
• Death is deemed imminent
• Significant cardiovascular or respiratory instability as determined by the treating therapist or medical staff
• Patients who are deemed to be agitated, aggressive or display unpredictable behaviours
• Patients with an active infection by a resistant organism
• Patients with an open sternum

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Manually analysed PSG data (gold standard) will be validated against manually analysed single forehead sensor data. PSG and equivalent single sensor sleep outcomes will be compared using paired t-tests or the Wilcoxon signed-rank test, depending on the distribution of the sleep outcome. Agreement between PSG and equivalent single sensor sleep outcomes will be evaluated using Bland-Altman plots. Similar analysis will be performed comparing automatically scored against manually scored sleep data. Environmental noise and light, and nursing interventions, will be linked to sleep data where able to analyse reasons for disrupted sleep.

Patients with delirium will be analysed and compared to patients without delirium. Delirium will be assessed twice daily during the study period using CAM-ICU (routinely collected in ICU).

For circadian rhythmicity, differential rhythmicity in the different biological parameters will be assessed with a modified version of the DryR analysis tool. Briefly, we will use a multiple mixed linear model with a subsequent model selection based on the Bayesian information criterion to identify differential rhythmic parameters in patients admitted to the ICU. The mixed linear model will include fixed effects from a harmonic regression model and a random effect (patient–specific) on the intercept that deals with the subject–to–subject variation and dependency of the repeated measures. Rhythmic parameters including amplitude and acrophase will be computed from the selected model for each of the conditions. This will identify the parameters that impact on circadian rhythms in the ICU. Also, the incidence of delirium will be collected as described above and analysed against the incidence and severity of circadian rhythm disruptions to explore any correlation between delirium and circadian rhythm abnormalities.

Furthermore, multiple regression analysis tests will be conducted to predict whether variations in lighting cycles (e.g., intensity, spectral power distribution) improve clinical measures for recovery (e.g., hours of sleep at night-time).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/07/2022
Actual
26/07/2022
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
30
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22460 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 37694 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 311542 0
Charities/Societies/Foundations
Name [1] 311542 0
The Prince Charles Hospital Foundation
Country [1] 311542 0
Australia
Funding source category [2] 311544 0
Other Collaborative groups
Name [2] 311544 0
Critical Care Research Group
Country [2] 311544 0
Australia
Primary sponsor type
Government body
Name
Metro North Hospital and Health Service
Address
The Prince Charles Hospital
Rode Road
Chermside, Queensland, 4032
Country
Australia
Secondary sponsor category [1] 312959 0
None
Name [1] 312959 0
Address [1] 312959 0
Country [1] 312959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310997 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 310997 0
Ethics committee country [1] 310997 0
Australia
Date submitted for ethics approval [1] 310997 0
08/02/2022
Approval date [1] 310997 0
17/03/2022
Ethics approval number [1] 310997 0
HREC/ 2022/QPCH/84211 & ID: 84211

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

Contacts
Principal investigator
Name 119634 0
Mr Oystein Tronstad
Address 119634 0
Critical Care Research Group,
Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, Queensland, 4032
Country 119634 0
Australia
Phone 119634 0
+61 422212452
Fax 119634 0
Email 119634 0
[email protected]
Contact person for public queries
Name 119635 0
Oystein Tronstad
Address 119635 0
Critical Care Research Group,
Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, Queensland, 4032
Country 119635 0
Australia
Phone 119635 0
+61 422212452
Fax 119635 0
Email 119635 0
[email protected]
Contact person for scientific queries
Name 119636 0
Oystein Tronstad
Address 119636 0
Critical Care Research Group,
Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, Queensland, 4032
Country 119636 0
Australia
Phone 119636 0
+61 422212452
Fax 119636 0
Email 119636 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data underlying published results will be shared upon reasonable request to the Principal Investigator.
When will data be available (start and end dates)?
Available for 5 years after publication.
Available to whom?
Data will be available to fellow researchers who provide a methodologically-sound proposal who are approved by the Principal Investigator
Available for what types of analyses?
Data will only be available to achieve the aims of the approved proposal.
How or where can data be obtained?
Data can be obtained through email request to the Principal Investigator, Oystein Tronstad ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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