Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
single night recording for each subject
Secondary outcome [1] 0 0
Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram
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
Sex
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
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
6/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/11/2019
Sample size
Target
Accrual to date
Final
30
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04326127