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Trial registered on ANZCTR


Registration number
ACTRN12615000945527
Ethics application status
Approved
Date submitted
30/08/2015
Date registered
9/09/2015
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of sleep monitoring techniques and the impact of the clinical environment on Intensive Care patients sleep.
Scientific title
An investigation of the application of actigraphy to assess sleep disturbance compared to polysomnography and subjective sleep assessments within the Intensive Care Unit.
Secondary ID [1] 287372 0
Nil
Universal Trial Number (UTN)
U1111-1173-1192.
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance
296053 0
Sleep fragmentation 296054 0
Sleep monitoring 296055 0
Clinical environment 296056 0
Condition category
Condition code
Public Health 296322 296322 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Concurrent sleep monitoring techniques applied to patients admitted to the intensive care environment, including polysomnography, actigraphy, patient self-reports and clinician based observations.

Sleep monitoring procedure:

Actigraphy: Participants will be fitted an omidirectional accelerometer wrist actigraphy watch, which detects movement used to identify activity/rest cycles. This device will monitoring rest/activity cycles for a 24 hour period.

Polysomnography: 24 hour polysomnography will be conducted, and requires the application of 9 small electrodes on the head and face to record the biophysiological features of the sleep cycle.

Patient self-assessment:Patients will be requested to complete the Richards-Campbell Sleep Questionnaire (RCSQ) and the Karolinska Sleepiness Scale (univariant scale). The RCQS is a 6 item scale that will be completed by the patient the following morning after the night recording, whilst the Karolinska Sleepiness Scale will be completed at three intervals with minimum of 6 hours between assessments to evaluate subjective sleepines
Participants who are able to complete the sleep self assessment questionnaires will be followed up in the clinical wards post ICU discharge to complete the Little Sleep Questionnaire (LSQ). This questionnaire explores patients perceived sleep quality at home compared to the ICU experience, and the factors that contributed to sleep disturbance or could have enhanced their sleep quality.

Nurses subjective assessment of sleep: Nursing staff will be required to complete an hourly sleep assessment, contained within the MetaVision electronic information system (iMDSoft). This assessment will require nursing staff to subjectively assess if the participant has been awake, asleep for less than 15 minutes, asleep for approximately 30 minutes, asleep for 45 minutes, asleep approximately 60 minutes of each hour of the monitoring period, or could not assess (e.g. due to sedation). This monitoring will conducted over the 24 hour monitoring period.

Monitoring of environmental factors considered to be the etiological cause of sleep disturbance; light, noise and clinical interactions.
Intervention code [1] 292717 0
Not applicable
Comparator / control treatment
Concurrent 24 hour sleep monitoring applied to participants admitted to Intensive Care, with polysomnography (the gold standard of sleep monitoring) acting as the control. Comparative sleep monitoring techniques being investigated will include actigraphy, observational recording of sleep duration, and participant self-reporting of sleep quality (Karolinska Sleepiness Scale and Richards-Campbell Sleep Questionnaire). Sleep monitoring techniques will be time synchronised to the monitoring of the clinical environment: light, noise and clinical intervention.
Control group
Active

Outcomes
Primary outcome [1] 295974 0
Primary outcome 1:To determine the accuracy of actigraphy compared to polysomnography in monitoring total sleep time and sleep fragmentation.
Timepoint [1] 295974 0
Timepoint: at the completion of 24 hours of continuous monitoring.
Primary outcome [2] 295975 0
Primary outcome 2: To evaluate the accuracy of subjective assessments (patient reports and clinical observations) of sleep compared to biophysiological sleep monitoring: polysomnography.
Timepoint [2] 295975 0
Timepoint: at the completion of 24 hours of continuous monitoring.
Primary outcome [3] 295976 0
Primary outcome 3: To report the composite impact of the noise levels greater than 70dB(A) and nocturnal exposure to artificial light on sleep.

Noise level will monitored an recorded in the decibel A weighted by a sound meter positioned at the head end of the patient's bed.

Light levels will monitored using a light meter to record luminance (Lux) and is the standard unit of measure in photometry, representative of the intensity of light perceived by the human eye. This device will positioned a head end of the patients bed.
Timepoint [3] 295976 0
Timepoint: at the completion of 24 hours of continuous monitoring.
Secondary outcome [1] 317083 0
Secondary outcome 1: To quanitfy the percentage of time spent in the stages of the sleep cycle (stage 1, 2, 3 and rapid eye movement) determined by polysomnography
Timepoint [1] 317083 0
Time point: Over a 24 hour period of sleep monitoring
Secondary outcome [2] 317084 0
Secondary outcome 2: Report the total sleep time acquired determine by polysomnography by Intensive care patients.
Timepoint [2] 317084 0
Time point: Over a 24 hour period of sleep monitoring
Secondary outcome [3] 342570 0
Patient perceived sleep quality at home compared to Intensive care and factors that contributed to sleep disturbance as assessed by the Little Sleep Questionnaire.
Timepoint [3] 342570 0
Post ICU discharge (within 7 days).

Eligibility
Key inclusion criteria
Over 18 years of age.
Admission to intensive care anticipated to be greater than 24 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be ineligible for the study if the treating ICU consultant determines the patient to:
1. Have significant neurological injury (Intra-cranial pressure >20mmHg in the past 24 hours, neurosurgical intervention in the past 3 days),
2. If patients are not suspected to survive for more than 24 hours,
3. Admissions with a confirmed or suspected drug overdose,
4. Patients who have been administered administered paralyzing agents within the past 24 hours,
5. Patients requiring a barbiturate infusion,
6. Patients admitted with a primary seizure disorder or assessed has having seizure activity,
7. Patients who are receiving palliative care or treatment withdrawal,
8. Patients with a known past medical history of Parkinson’s or Alzheimer’s Disease,
9. Inadequate English language skills,
10. Facial injuries that prohibit the placement of the PSG electrodes,
11. Injuries that preclude the application of actigraphy,
12. Patients with known spinal cord injury or neuromuscular dege nerative conditions such as Guillain Barrre Syndrome, and
13. Clinically suspected encephalopathies: septic encephalopathy, hepatic encephalopathy or uremic encephalopathy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sixty-seven (67) participants are needed to determine the strength and direction of correlations between PSG and actigraphy measurements of sleep quality and quantity, and the ability of actigraphy to correctly distinguish between sleep and wakeful state with 80% power, 95% significance and to detect a medium effect size (correlation co-efficient Rho, p = 0.3).

Descriptive statistics including means and standard deviations will be used to describe the patient cohort, with medians and interquartile ranges reported for non-parametric data. Data will be analysed using Statistical Packages for Social Sciences (version 20.)

Actigraphy and behavioural assessment data will be compared with PSG data using the Wilcoxon nonparametric tests, paired t-tests and Pearson correlations. All p values > 0.05 will be considered statistically significant.

Multiple regression analysis will be conducted to explore the relationship between the variables being investigated. In addition, a Blandt-Altman plot will used to investigate the agreement between PSG and actigraphy for arousal and sleep, and the Cohen-Kappa test will be used to test agreement between nominal data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/10/2016
Actual
7/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
67
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 4273 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 10223 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 291934 0
Charities/Societies/Foundations
Name [1] 291934 0
Canberra Hospital Foundation
Country [1] 291934 0
Australia
Funding source category [2] 294310 0
Charities/Societies/Foundations
Name [2] 294310 0
Mortara Instrument Aust. Pty. Ltd.
Country [2] 294310 0
Australia
Primary sponsor type
Individual
Name
Assistant Professor Lori Delaney
Address
Disciplines of Nursing and Midwifery
University Drive
University of Canberra
Bruce ACT 2601
Country
Australia
Secondary sponsor category [1] 290603 0
Individual
Name [1] 290603 0
Associated Professor Dr Frank Van Haren
Address [1] 290603 0
Intensive Care Unit
The Canberra Hospital
Yambe Drive
Garran ACT 2605
Country [1] 290603 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293435 0
Australian Capital Territory Human Research Ethics Committee
Ethics committee address [1] 293435 0
Ethics committee country [1] 293435 0
Australia
Date submitted for ethics approval [1] 293435 0
25/04/2016
Approval date [1] 293435 0
Ethics approval number [1] 293435 0
Ethics committee name [2] 296076 0
Ethics committee address [2] 296076 0
Ethics committee country [2] 296076 0
Australia
Date submitted for ethics approval [2] 296076 0
07/07/2016
Approval date [2] 296076 0
16/09/2016
Ethics approval number [2] 296076 0
ETH.5.16.071

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

Contacts
Principal investigator
Name 59918 0
Ms Lori Delaney
Address 59918 0
Disciplines of Nursing and Midwifery
University Drive
University of Canberra
Bruce ACT 2601
Country 59918 0
Australia
Phone 59918 0
+61 2 6201 2108
Fax 59918 0
+61 2 6201 5128
Email 59918 0
lori.delaney@canberra.edu.au
Contact person for public queries
Name 59919 0
Lori Delaney
Address 59919 0
Disciplines of Nursing and Midwifery
University Drive
University of Canberra
Bruce ACT 2601
Country 59919 0
Australia
Phone 59919 0
+61 2 6201 2108
Fax 59919 0
+61 2 6201 5128
Email 59919 0
lori.delaney@canberra.edu.au
Contact person for scientific queries
Name 59920 0
Lori Delaney
Address 59920 0
Disciplines of Nursing and Midwifery
University Drive
University of Canberra
Bruce ACT 2601
Country 59920 0
Australia
Phone 59920 0
+61 2 6201 2108
Fax 59920 0
+61 2 6201 5128
Email 59920 0
lori.delaney@canberra.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIInvestigating the application of motion accelerometers as a sleep monitoring technique and the clinical burden of the intensive care environment on sleep quality: study protocol for a prospective observational study in Australia2018https://doi.org/10.1136/bmjopen-2017-019704
N.B. These documents automatically identified may not have been verified by the study sponsor.