Sleep-Disordered BreathingNCT05647746
Comparative Assessment of Compumedics Somfit Sleep Monitoring Device
A study testing Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system in people with Sleep-Disordered Breathing, run by Compumedics Limited at 1 site in Australia.
Trial summary
To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep-Disordered Breathing
- What is being tested?
- Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Dec 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Comparison of Compumedics Somfit Sleep Monitoring Device Against Home Sleep Apnoea Testing Device (Itamar WatchPAT) and Polysomnography
To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing
Read the detailed description
Sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and sleep). Poor quality and fragmented sleep leads to an increase in the risk for development of chronic health conditions. Given the importance of good quality sleep and its critical role in overall well-being, there is a need for regular monitoring and assessment of sleep quality in individuals. However, current technologies will only allow for this to be performed in sleep clinics and with the help of full polysomnography (PSG) systems which require the patients to spend a night at the clinic with several wired electrodes connected to their scalp. This "gold standard" technology is expensive and therefore does not allow to meet public health demand for diagnosis of sleep disorders, especially obstructive sleep apnea (OSA) and also can be uncomfortable for the patients and distort their natural sleep architecture. To solve this problem, Compumedics has recently developed a miniaturized, portable, automated and affordable sleep monitoring system with code name of "Somfit" which is attached to patients' forehead and can be used in the comfort of patients' home. While Somfit has already gained TGA approval, the aim of this study is to compare Somfit with the "gold standard" PSG and another approved portable sleep testing device, Itamar WatchPAT One, in terms of accuracy of characterising sleep neurological architecture and diagnosing OSA, with the objective of applying for the international regulatory approvals.
- Conditions
- Sleep-Disordered Breathing
- Being tested
- Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG systemDevice
Each intervention is a separate diagnostic device. They will all be operating at the same time
What is being measured
The primary outcome is the main question the study is designed to answer.
The AHI difference between the test device (Somfit) and gold standard (PSG)
AHI is the apnea hypopnea index, main measure of presence/severity of OSA (obstructive sleep apnea). it will test the null hypothesis that Somfit AHI is not equivalent to the AHI reported by PSG
Measured: 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
The AHI difference between the test device (Somfit) and predicate device (WatchPAT)
AHI is the apnea hypopnea index, main measure of presence/severity of OSA (obstructive sleep apnea). it will test the null hypothesis that Somfit AHI is not equivalent to the AHI reported by PSG
Measured: 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 outcomes (2)
Difference between hypnogram percent agreements between WatchPAT and PSG, and between Somfit and PSG
It will test the null hypothesis that the accuracy of sleep staging performed by the test device (Somfit) is inferior to that of the predicate device (WatchPAT)
Measured: 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
Hypnogram percent agreement between Somfit and PSG
It will test the null hypothesis that the accuracy of sleep staging performed by the test device (Somfit) is inferior to that demonstrated by the accredited sleep technologists
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start10 Dec 2022
- Primary completion28 Feb 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- As the study investigate performances of the diagnostic equipment, the three diagnostic devices can be applied to the single group of patients at the same time
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Compumedics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647746
- Sponsor's protocol ID
- AJ259
- Status last verified
- Feb 2024
- First submitted
- 1 Dec 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Comparison of Compumedics Somfit Sleep Monitoring Device Against Home Sleep Apnoea Testing Device (Itamar WatchPAT) and Polysomnography
- ClinicalTrials.gov ID
- NCT05647746
- Acronym / sponsor ID
- AJ259
- Conditions
- Sleep-Disordered Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Compumedics LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing
Detailed description
Sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and sleep). Poor quality and fragmented sleep leads to an increase in the risk for development of chronic health conditions. Given the importance of good quality sleep and its critical role in overall well-being, there is a need for regular monitoring and assessment of sleep quality in individuals. However, current technologies will only allow for this to be performed in sleep clinics and with the help of full polysomnography (PSG) systems which require the patients to spend a night at the clinic with several wired electrodes connected to their scalp. This "gold standard" technology is expensive and therefore does not allow to meet public health demand for diagnosis of sleep disorders, especially obstructive sleep apnea (OSA) and also can be uncomfortable for the patients and distort their natural sleep architecture. To solve this problem, Compumedics has recently developed a miniaturized, portable, automated and affordable sleep monitoring system with code name of "Somfit" which is attached to patients' forehead and can be used in the comfort of patients' home. While Somfit has already gained TGA approval, the aim of this study is to compare Somfit with the "gold standard" PSG and another approved portable sleep testing device, Itamar WatchPAT One, in terms of accuracy of characterising sleep neurological architecture and diagnosing OSA, with the objective of applying for the international regulatory approvals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Model description
- As the study investigate performances of the diagnostic equipment, the three diagnostic devices can be applied to the single group of patients at the same time
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG systemEach intervention is a separate diagnostic device. They will all be operating at the same time | Device | – |
Primary outcome
The AHI difference between the test device (Somfit) and gold standard (PSG)
Time frame: 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
AHI is the apnea hypopnea index, main measure of presence/severity of OSA (obstructive sleep apnea). it will test the null hypothesis that Somfit AHI is not equivalent to the AHI reported by PSG
The AHI difference between the test device (Somfit) and predicate device (WatchPAT)
Time frame: 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
AHI is the apnea hypopnea index, main measure of presence/severity of OSA (obstructive sleep apnea). it will test the null hypothesis that Somfit AHI is not equivalent to the AHI reported by PSG
2 secondary outcomes
Difference between hypnogram percent agreements between WatchPAT and PSG, and between Somfit and PSG
Time frame: 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
Hypnogram percent agreement between Somfit and PSG
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Sleep-Disordered Breathing
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system in people with Sleep-Disordered Breathing, run by Compumedics Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The AHI difference between the test device (Somfit) and gold standard (PSG) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.