Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000628246
Ethics application status
Approved
Date submitted
11/04/2018
Date registered
20/04/2018
Date last updated
12/08/2019
Date data sharing statement initially provided
31/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleeping position during sleep tests and at home.
Scientific title
The effect of sleep study instrumentation on habitual sleeping position in patients referred for sleep study testing.
Secondary ID [1] 294546 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 307325 0
Condition category
Condition code
Respiratory 306433 306433 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to determine if there are systematic differences in habitual body position during sleep when sleep is recorded in the hospital with full polysomnographic equipment applied versus at the patient's home with simple body position measurements only.
The intervention arm will consist of the application of standard clinical polysomnogrpahic equipment by trained scientific staff at a NATA accredited sleep laboratory (Monash Lung and Sleep). The equipment includes electroencephalograph, electromyography, electrooculography, electrocardiogram, respiratory effort plethysmography, nasal pressure, oxygen saturations applied according to standard methods as outlined by the American Academy of Sleep Medicine and as audited by NATA.
This intervention is performed for one night with full polysomnography performed either at the hospital (in-lab) or at the patient's home (full at home polysomnography).
For each patient enrolled the study with equipment applied will be performed for a single night either at Monash Lung and Sleep laboratory or at the patient's home.
Intervention code [1] 300844 0
Not applicable
Comparator / control treatment
The control arm of this study will consist of three nights measurement of body position during sleep as recorded by the NightShift device - a commercially available body position recorder that is worn around the neck.
The duration of the control arm will be three nights.
Control group
Active

Outcomes
Primary outcome [1] 305444 0
Percentage of sleep spent in the supine position
- This number is calculated by recording the time spent asleep in the supine position (sleep measured by EEG and supine position measured by piezoelectric sensor) and dividing this by the total sleep time (measured with EEG recording).
Timepoint [1] 305444 0
One night for "treatment arm" group, three nights for "control arm"
Primary outcome [2] 305445 0
Time spent supine.
- The time spent supine is recorded using a body position sensor worn over the sternum and which is used as part of standard clinical measurement.
Timepoint [2] 305445 0
One night for "treatment arm" group, three nights for "control arm".
Secondary outcome [1] 345260 0
Number of position changes during the night.
- Each time the participant changes position is assessed using the body position sensor, which provides a continuous recording of body position as it is worn over the sternum.
Timepoint [1] 345260 0
One night for "treatment arm" group, three nights for "control arm".

Eligibility
Key inclusion criteria
Patients awaiting sleep study investigation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2018
Actual
15/05/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
150
Accrual to date
107
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10689 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 22411 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 299169 0
Hospital
Name [1] 299169 0
Monash Lung and Sleep
Country [1] 299169 0
Australia
Primary sponsor type
Hospital
Name
Monash Lung and Sleep
Address
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria
3168
Country
Australia
Secondary sponsor category [1] 298428 0
None
Name [1] 298428 0
Address [1] 298428 0
Country [1] 298428 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300095 0
Monash Health
Ethics committee address [1] 300095 0
246 Clayton Rd
Clayton
Victoria
3168
Ethics committee country [1] 300095 0
Australia
Date submitted for ethics approval [1] 300095 0
29/03/2018
Approval date [1] 300095 0
27/04/2018
Ethics approval number [1] 300095 0

Summary
Brief summary
Sleep disordered breathing is common with obstructive sleep apnoea (OSA) being the predominant type. OSA is the repetitive complete obstruction (apnoea) or partial obstruction (hypopnoea) of the collapsible part of the upper airway during sleep. Symptoms include excessive daytime sleepiness, unrefreshing sleep and fatigue. Numerous studies have shown that OSA is associated with depression, hypertension, stroke, motor vehicle accidents, and other cardiovascular disorders. Obstructive sleep apnoea (OSA) is diagnosed with polysomnography. Respiratory events, either apnoeas or hypopnoeas, frequently worsen when lying in the supine position. Previous data have shown that 60% of patients with OSA have supine predominant OSA (OSA that occurs at least twice as frequently in the supine position) and 25% of patients have OSA that is solely present when lying supine (Joosten et al, 2012). In this context, knowledge of OSA severity in different body positions is crucial to informing patient management. Polysomnography involves sleeping while attached to a significant number of sensors and electrodes to measure sleep quality and breathing and cardiac parameters. Because of the inconvenience of the test, patients commonly report that the position they sleep in during polysomnography does not represent what they usually do at home, with patients most commonly reporting that they sleep more in the supine position that they would normally do. However, patient reports of habitual body position during sleep may not necessarily be accurate and whether body position in polysomnography reflects habitual body position at home has never been systematically addressed in a research study. Therefore, our project aims to look at the body position of patients during polysomnography in comparison with the habitual body position of patients at home. We intend to enrol patients having sleep studies in our tertiary academic sleep unit, and provide them with a small, unobtrusive body position sensor to detect their habitual body position in their home over the subsequent week. We hypothesise that there will be a discordance between polysomnography determined body position and habitual sleeping body position, with less time spent supine when at home that during polysomnography, given multiple factors. These could include less restriction due to leads, changes in bedroom environment and bed size.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82550 0
A/Prof Garun Hamilton
Address 82550 0
Monash Lung and Sleep
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria
3168
Country 82550 0
Australia
Phone 82550 0
+61 3 95942900
Fax 82550 0
Email 82550 0
garun.hamilton@monashhealth.org.au
Contact person for public queries
Name 82551 0
Dr Simon Joosten
Address 82551 0
Monash Lung and Sleep
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria
3168
Country 82551 0
Australia
Phone 82551 0
+61 3 95942900
Fax 82551 0
Email 82551 0
simon.joosten@monash.edu
Contact person for scientific queries
Name 82552 0
Dr Simon Joosten
Address 82552 0
Monash Lung and Sleep
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria
3168
Country 82552 0
Australia
Phone 82552 0
+61 3 95942900
Fax 82552 0
Email 82552 0
drjoosten@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Outside of the listed members of the research team nobody will have access to individual patient data. The data will be collected for the purpose of analysis for this project.


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
EmbaseBody position during laboratory and home polysomnography compared to habitual sleeping position at home.2022https://dx.doi.org/10.5664/jcsm.9990
N.B. These documents automatically identified may not have been verified by the study sponsor.