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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04326127




Registration number
NCT04326127
Ethics application status
Date submitted
26/03/2020
Date registered
30/03/2020
Date last updated
31/03/2020

Titles & IDs
Public title
Evaluation of Compumedics "Somfit" Device
Scientific title
Performance Evaluation of the Compumedics "Somfit" Sleep Monitoring Device
Secondary ID [1] 0 0
SOMFIT02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)

Control - Healthy volunteers

Case - Volunteers with diagnosed sleep apnea


Treatment: Devices: Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
Data were recorded overnight by both devices simultaneously

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison between raw EEG signals - Direct comparison of Raw EEG data between Somfit and Grael system on an epoch by epoch basis (with each epoch being equivalent to 30 secs) to test and validate Somfit for data acquisition, display and record of Raw EEG data.
Timepoint [1] 0 0
single night recording for each subject
Secondary outcome [1] 0 0
Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram - Epoch-by-epoch comparison between manual and automatic scoring of sleep data recorded by Somfit and Grael devices
Timepoint [1] 0 0
single night recording for each subject

Eligibility
Key inclusion criteria
- Individuals age between 18 to 75

- Be able to give informed consent

- Individuals with diagnosed Obstructive Sleep Apnoea (OSA)
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Less than 18 years of age

- Greater than 75 years of age

- Unable or not willing to provide informed consent

- Need for nursing care

- Currently working nightshift

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
SleepMetrics Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3752 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Compumedics Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To study whether Somfit is substantially equivalent to an existing approved device (i.e.
Compumedic's Grael System) to assist in elucidating sleep disorders.
Trial website
https://clinicaltrials.gov/show/NCT04326127
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth Kealy
Address 0 0
Sleepmetrics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications