- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01925430
The Evaluation of a New Sleep Algorithm
May 1, 2014 updated by: ResMed
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2153
- RedMed Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Volunteers who are employees within a medical device company
Description
Inclusion Criteria:
- => 18yrs old
- can read and write English
- Provide informed written consent
Exclusion Criteria:
- Unable to participate for the full duration of the study
- An individual who is deemed unsuitable to participate in the opinion of the investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Comparative product
A device which monitors sleep/wake states
|
A non-invasive device worn on the arm or leg.
It monitors body movement and sleep/wake states
Other Names:
|
Screening device
This device will screen for sleep-breathing disorders
|
Non-invasive device worn over clothes during sleep.
Used to screen for sleep-disordered breathing conditions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total sleep time
Time Frame: 12 hrs
|
To measure the total sleep time recorded and analysed on the device using the new algorithm
|
12 hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of arousals during sleep
Time Frame: 12 hrs
|
To compare the data acquired of the new device's algorithm against a pre-existing device detailing the frequency of sleep and wake periods
|
12 hrs
|
Duration of arousals during sleep
Time Frame: 12 hrs
|
To compare the data acquired of the new device's algorithm against a pre-existing device detailing the duration of sleep and wake
|
12 hrs
|
Occurrence of arousals during sleep
Time Frame: 12 hrs
|
To compare the data acquired of the new device's algorithm against a pre-existing device detailing when sleep and wake periods occurred
|
12 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Klaus Schindhelm, BE PhD, The University of New South Wales, Australia & ResMed Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
February 1, 2014
Study Registration Dates
First Submitted
August 15, 2013
First Submitted That Met QC Criteria
August 15, 2013
First Posted (ESTIMATE)
August 19, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
May 2, 2014
Last Update Submitted That Met QC Criteria
May 1, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MA06082013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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