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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01925430




Registration number
NCT01925430
Ethics application status
Date submitted
15/08/2013
Date registered
19/08/2013
Date last updated
2/05/2014

Titles & IDs
Public title
The Evaluation of a New Sleep Algorithm
Scientific title
The Evaluation of a New Sleep/Wake State Algorithm
Secondary ID [1] 0 0
MA06082013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Screening device
Treatment: Devices - Comparative product

Comparative product - A device which monitors sleep/wake states

Screening device - This device will screen for sleep-breathing disorders


Treatment: Devices: Screening device
Non-invasive device worn over clothes during sleep. Used to screen for sleep-disordered breathing conditions.

Treatment: Devices: Comparative product
A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total sleep time
Timepoint [1] 0 0
12 hrs
Secondary outcome [1] 0 0
Frequency of arousals during sleep
Timepoint [1] 0 0
12 hrs
Secondary outcome [2] 0 0
Duration of arousals during sleep
Timepoint [2] 0 0
12 hrs
Secondary outcome [3] 0 0
Occurrence of arousals during sleep
Timepoint [3] 0 0
12 hrs

Eligibility
Key inclusion criteria
- => 18yrs old

- can read and write English

- Provide informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
RedMed Ltd - Sydney
Recruitment postcode(s) [1] 0 0
2153 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01925430
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm, BE PhD
Address 0 0
The University of New South Wales, Australia & ResMed Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01925430