HealthyNCT01925430
The Evaluation of a New Sleep Algorithm
An observational study of Healthy, run by ResMed at 1 site in Australia.
Trial summary
A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states. The aim of this study is to evaluate the performance of this new algorithm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Screening device and Comparative product
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2013to Feb 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers who are employees within a medical device company
Who may be able to join
- => 18yrs old
- can read and write English
- Provide informed written consent
Who cannot join
- Unable to participate for the full duration of the study
- An individual who is deemed unsuitable to participate in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of a New Sleep/Wake State Algorithm
A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states. The aim of this study is to evaluate the performance of this new algorithm. This prototype will be compared against a commercially available device which monitors sleep/wake patterns. Volunteers will be asked to wear the prototype and comparative devices for 1-2 nights. The data from both devices will be downloaded after the completion of the study and analysis wil be performed to compare the two recordings.
- Conditions
- Healthy
- Being tested
- Screening device, Comparative product
- Keywords
- Observational, Sleep, Algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening deviceDevice
Also called ApneaLink, Actigraphy
Non-invasive device worn over clothes during sleep. Used to screen for sleep-disordered breathing conditions.
Comparative productDevice
Also called Actiwatch 2 (Respironics), Patient data recorder, Actigraphy
A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states
| Study group | Role | What they receive |
|---|---|---|
| Comparative product | A device which monitors sleep/wake states Receives: Device: Comparative product | |
| Screening device | This device will screen for sleep-breathing disorders Receives: Device: Screening device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time
To measure the total sleep time recorded and analysed on the device using the new algorithm
Measured: 12 hrs
Secondary outcomes (3)
Frequency of arousals during sleep
To compare the data acquired of the new device's algorithm against a pre-existing device detailing the frequency of sleep and wake periods
Measured: 12 hrs
Duration of arousals during sleep
To compare the data acquired of the new device's algorithm against a pre-existing device detailing the duration of sleep and wake
Measured: 12 hrs
Occurrence of arousals during sleep
To compare the data acquired of the new device's algorithm against a pre-existing device detailing when sleep and wake periods occurred
Measured: 12 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Schindhelm, BE PhD, Principal investigator, The University of New South Wales, Australia & ResMed Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925430
- Sponsor's protocol ID
- MA06082013
- Status last verified
- May 2014
- First submitted
- 15 Aug 2013
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a New Sleep/Wake State Algorithm
- ClinicalTrials.gov ID
- NCT01925430
- Acronym / sponsor ID
- MA06082013
- Conditions
- Healthy
- Keywords
- Observational, Sleep, Algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Aug 2013 (estimated)
- 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.
A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states. The aim of this study is to evaluate the performance of this new algorithm. This prototype will be compared against a commercially available device which monitors sleep/wake patterns. Volunteers will be asked to wear the prototype and comparative devices for 1-2 nights. The data from both devices will be downloaded after the completion of the study and analysis wil be performed to compare the two recordings.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparative product | – | Device: Comparative productA device which monitors sleep/wake states |
| Screening device | – | Device: Screening deviceThis device will screen for sleep-breathing disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers who are employees within a medical device company
Key inclusion criteria (3 listed)
- => 18yrs old
- can read and write English
- Provide informed written consent
Key exclusion criteria (2 listed)
- Unable to participate for the full duration of the study
- An individual who is deemed unsuitable to participate in the opinion of the investigator
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 |
|---|---|---|
| Screening deviceAlso: ApneaLink, ActigraphyNon-invasive device worn over clothes during sleep. Used to screen for sleep-disordered breathing conditions. | Device | Screening device |
| Comparative productAlso: Actiwatch 2 (Respironics), Patient data recorder, ActigraphyA non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states | Device | Comparative product |
Primary outcome
Total sleep time
Time frame: 12 hrs
To measure the total sleep time recorded and analysed on the device using the new algorithm
3 secondary outcomes
Frequency of arousals during sleep
Time frame: 12 hrs
Duration of arousals during sleep
Time frame: 12 hrs
Occurrence of arousals during sleep
Time frame: 12 hrs
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 2 May 2014.
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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.
Klaus Schindhelm, BE PhD principal investigator
The University of New South Wales, Australia & ResMed Ltd
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 Healthy, run by ResMed 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 2 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 2 May 2014. 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?
Total sleep time (time frame: 12 hrs). 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 2 May 2014.