ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obstructive sleep apnoea

Condition category

Condition code

Respiratory

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]

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]

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]

One night for "treatment arm" group, three nights for "control arm"

Primary outcome [2]

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]

One night for "treatment arm" group, three nights for "control arm".

Secondary outcome [1]

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]

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?

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]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Monash Lung and Sleep

Address [1]

Monash Lung and Sleep
246 Clayton Rd
Clayton
Victoria
3168

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health

Ethics committee address [1]

246 Clayton Rd
Clayton 
Victoria
3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/03/2018

Approval date [1]

27/04/2018

Ethics approval number [1]

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

A/Prof Garun Hamilton

Address

Monash Lung and Sleep
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria
3168

Country

Australia

Phone

+61 3 95942900

Fax

[email protected]

Contact person for public queries

Name

Simon Joosten

Address

Monash Lung and Sleep
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria
3168

Country

Australia

Phone

+61 3 95942900

Fax

[email protected]

Contact person for scientific queries

Name

Simon Joosten

Address

Monash Lung and Sleep
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria
3168

Country

Australia

Phone

+61 3 95942900

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Body position during laboratory and home polysomnography compared to habitual sleeping position at home.	2022	https://dx.doi.org/10.5664/jcsm.9990

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically