Sleep ApneaNCT04326127
Evaluation of Compumedics "Somfit" Device
An observational study of Sleep Apnea, run by Compumedics Limited at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Nov 2019to 19 Nov 2019
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 volunteers were invited to participate in this study. 15 participants will be selected among healthy volunteers, by advertising to the general public. The remaining 15 will be among patients with diagnosed sleep apnea who visit SleepMetrics clinic as part of their routine treatment.
Who may be able to join
- Individuals age between 18 to 75
- Be able to give informed consent
- Individuals with diagnosed Obstructive Sleep Apnoea (OSA)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Evaluation of the Compumedics "Somfit" Sleep Monitoring Device
To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.
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 will cause discomfort for the patients in a long run. To solve this problem, Compumedics has recently developed a miniaturized, portable and affordable sleep monitoring system with code name of "Somfit" which can be used in the comfort of patients' home. The aim of this study is to validate Somfit for home based sleep studies.
- Conditions
- Sleep Apnea
- Being tested
- Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal 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.
Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)Device
Data were recorded overnight by both devices simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy volunteers Receives: Device: Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system) | |
| Case | Volunteers with diagnosed sleep apnea Receives: Device: Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single night recording for each subject
Secondary outcomes (1)
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
Measured: single night recording for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start6 Nov 2019
- Primary completion19 Nov 2019
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Compumedics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Kealy, Principal investigator, Sleepmetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326127
- Sponsor's protocol ID
- SOMFIT02
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the Compumedics "Somfit" Sleep Monitoring Device
- ClinicalTrials.gov ID
- NCT04326127
- Acronym / sponsor ID
- SOMFIT02
- Conditions
- Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Compumedics LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 30 Mar 2020 (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 an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.
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 will cause discomfort for the patients in a long run. To solve this problem, Compumedics has recently developed a miniaturized, portable and affordable sleep monitoring system with code name of "Somfit" which can be used in the comfort of patients' home. The aim of this study is to validate Somfit for home based sleep studies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)Healthy volunteers |
| Case | – | Device: Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)Volunteers with diagnosed sleep apnea |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 volunteers were invited to participate in this study. 15 participants will be selected among healthy volunteers, by advertising to the general public. The remaining 15 will be among patients with diagnosed sleep apnea who visit SleepMetrics clinic as part of their routine treatment.
Key inclusion criteria (3 listed)
- Individuals age between 18 to 75
- Be able to give informed consent
- Individuals with diagnosed Obstructive Sleep Apnoea (OSA)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| 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 | Device | Case, Control |
Primary outcome
Comparison between raw EEG signals
Time frame: single night recording for each subject
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.
1 secondary outcome
Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram
Time frame: single night recording for each subject
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 31 Mar 2020.
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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.
Elizabeth Kealy principal investigator
Sleepmetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, 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 31 Mar 2020. 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?
Comparison between raw EEG signals (time frame: single night recording for each subject). 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 31 Mar 2020.