Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000600842
Ethics application status
Approved
Date submitted
23/03/2021
Date registered
20/05/2021
Date last updated
20/05/2021
Date data sharing statement initially provided
20/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sleep parameter validation of a consumer home sleep monitoring device, EMFIT Quantified Sleep (QS), against Polysomnography
Scientific title
Validation of EMFIT QS sleep measurements against Polysomnography in adults
Secondary ID [1] 303761 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disorders 321250 0
Condition category
Condition code
Respiratory 319032 319032 0 0
Sleep apnoea
Neurological 319346 319346 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The EMFIT QS (Quantified Sleep), an unobtrusive, contact-free sleep monitoring device, that can be places under a bed mattress and is used for tracking the changes in individual’s sleep. This device provides heart and respiration rate measurements, a sleep stage estimation, sleep quality analysis, and heart rate variability.

Participants underwent a single-night clinical PSG study, and the same sleep measurements from PSG and EMFIT were simultaneously collected. Since EMFIT has been set up under the mattress, their usual sleep study by PSG has not been disrupted by EMFIT and they didn't notice the existence of the devices under the mattress.
Intervention code [1] 320075 0
Not applicable
Comparator / control treatment
The sleep measurements from EMFIT is validated against those obtained from the gold standard, Polysomnography.
Control group
Active

Outcomes
Primary outcome [1] 326937 0
validation of EMFIT QS measurement of sleep duration was determined by comparison with PSG measurements using Bland-Altman plots.

Timepoint [1] 326937 0
Since the start of the data collection
Primary outcome [2] 327527 0
validation of EMFIT QS continuous measurements of heart rate was determined by comparison with PSG measurements using epoch-by-epoch analysis,
Timepoint [2] 327527 0
Since the start of the data collection
Primary outcome [3] 327556 0
validation of EMFIT QS measurement of sleep onset latency was determined by comparison with PSG measurements using Bland-Altman plots.
Timepoint [3] 327556 0
Since the start of the data collection
Secondary outcome [1] 393186 0
validation of EMFIT QS measurement of wake after sleep onset was determined by comparison with PSG measurements using Bland-Altman plots. The outcome is primary.
Timepoint [1] 393186 0
Since the start of the data collection
Secondary outcome [2] 395654 0
validation of EMFIT QS measurement of sleep stages was determined by comparison with PSG measurements using Bland-Altman plots. The outcome is primary.
Timepoint [2] 395654 0
Since the start of the data collection

Eligibility
Key inclusion criteria
i. Enrolled in the Prince Charles Hospital Sleep Disorders Centre and undergoing some form of sleep study.
ii. At least 18 years of age
iii. Ability to read and converse in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other illnesses that will limit participation, including cognitive disorders preventing provision of informed consent, insomnia preventing sleep, and medication use that interferes with sleep

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The overall agreement between EMFIT and PSG was assessed using Bland-Altman plots. Also, pairwise comparison between the sleep summary measures and epoch-by-epoch analysis on the continuous measures of heart rate and sleep stages estimation have been done.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/12/2019
Date of last participant enrolment
Anticipated
Actual
23/07/2020
Date of last data collection
Anticipated
Actual
23/07/2020
Sample size
Target
30
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18988 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 33503 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 308169 0
Other
Name [1] 308169 0
Commonwealth Scientific and Industrial Research Organisation
Country [1] 308169 0
Australia
Primary sponsor type
Other
Name
Commonwealth Scientific and Industrial Research Organisation
Address
Level 5 - UQ Health Sciences Building, Fig Tree drive, RBWH, Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 308939 0
None
Name [1] 308939 0
Nil
Address [1] 308939 0
Nil
Country [1] 308939 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308154 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 308154 0
Ethics committee country [1] 308154 0
Australia
Date submitted for ethics approval [1] 308154 0
Approval date [1] 308154 0
07/11/2019
Ethics approval number [1] 308154 0

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

Contacts
Principal investigator
Name 109722 0
Dr Qing Zhang
Address 109722 0
Australian e-Health Research Centre, CSIRO
Level 5, UQ Health Science Building, Fig Tree Drive, RBWH, Herston, QLD, 4029
Country 109722 0
Australia
Phone 109722 0
+61732533630
Fax 109722 0
Email 109722 0
qing.zhang@csiro.au
Contact person for public queries
Name 109723 0
Qing Zhang
Address 109723 0
Australian e-Health Research Centre, CSIRO
Level 5, UQ Health Science Building, Fig Tree Drive, RBWH, Herston, QLD, 4029
Country 109723 0
Australia
Phone 109723 0
+61732533630
Fax 109723 0
Email 109723 0
qing.zhang@csiro.au
Contact person for scientific queries
Name 109724 0
Qing Zhang
Address 109724 0
Australian e-Health Research Centre, CSIRO
Level 5, UQ Health Science Building, Fig Tree Drive, RBWH, Herston, QLD, 4029
Country 109724 0
Australia
Phone 109724 0
+61732533630
Fax 109724 0
Email 109724 0
qing.zhang@csiro.au

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
SourceTitleYear of PublicationDOI
EmbaseA validation study of a ballistocardiograph sleep tracker against polysomnography.2022https://dx.doi.org/10.5664/jcsm.9754
N.B. These documents automatically identified may not have been verified by the study sponsor.