The Evaluation of a New Sleep Algorithm
The Evaluation of a New Sleep/Wake State Algorithm
1 other identifier
observational
36
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2013
CompletedFirst Posted
Study publicly available on registry
August 19, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMay 2, 2014
May 1, 2014
3 months
August 15, 2013
May 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total sleep time
To measure the total sleep time recorded and analysed on the device using the new algorithm
12 hrs
Secondary Outcomes (3)
Frequency of arousals during sleep
12 hrs
Duration of arousals during sleep
12 hrs
Occurrence of arousals during sleep
12 hrs
Study Arms (2)
Comparative product
A device which monitors sleep/wake states
Screening device
This device will screen for sleep-breathing disorders
Interventions
Non-invasive device worn over clothes during sleep. Used to screen for sleep-disordered breathing conditions.
A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states
Eligibility Criteria
Volunteers who are employees within a medical device company
You may qualify if:
- =\> 18yrs old
- can read and write English
- Provide informed written consent
You may not qualify if:
- Unable to participate for the full duration of the study
- An individual who is deemed unsuitable to participate in the opinion of the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (1)
RedMed Ltd
Sydney, New South Wales, 2153, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Schindhelm, BE PhD
The University of New South Wales, Australia & ResMed Ltd
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2013
First Posted
August 19, 2013
Study Start
November 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
May 2, 2014
Record last verified: 2014-05