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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05647746




Registration number
NCT05647746
Ethics application status
Date submitted
1/12/2022
Date registered
12/12/2022
Date last updated
7/02/2024

Titles & IDs
Public title
Comparative Assessment of Compumedics Somfit Sleep Monitoring Device
Scientific title
Performance Comparison of Compumedics Somfit Sleep Monitoring Device Against Home Sleep Apnoea Testing Device (Itamar WatchPAT) and Polysomnography
Secondary ID [1] 0 0
AJ259
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system

Treatment: Devices: Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system
Each intervention is a separate diagnostic device. They will all be operating at the same time
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The AHI difference between the test device (Somfit) and gold standard (PSG)
Timepoint [1] 0 0
Data required for the primary outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings
Primary outcome [2] 0 0
The AHI difference between the test device (Somfit) and predicate device (WatchPAT)
Timepoint [2] 0 0
Data required for this primary outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings
Secondary outcome [1] 0 0
Difference between hypnogram percent agreements between WatchPAT and PSG, and between Somfit and PSG
Timepoint [1] 0 0
Data required for this outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings
Secondary outcome [2] 0 0
Hypnogram percent agreement between Somfit and PSG
Timepoint [2] 0 0
Data required for this outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings

Eligibility
Key inclusion criteria
- Individuals aged 18 years or over

- Be able to give informed consent

- Referral for a diagnostic sleep study with indication of suspected sleep disordered
breathing or history of diagnosed sleep disordered breathing
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Less than 18 years of age

- Unable or not willing to provide informed consent

- Need for nursing attendance during the time between 9 pm and 9 am

- Use of any OSA treatments during any part of the PSG study

- Previous reaction to skin preparation, tapes and electrode gels used at PSG

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2023
Sample size
Target
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
VU
Recruitment hospital [1] 0 0
SleepMetrics Pty Ltd - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

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 the existing approved devices for full
polysomnography and home sleep apnea testing
Trial website
https://clinicaltrials.gov/ct2/show/NCT05647746
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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