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Clinical Trials/NCT01925430
NCT01925430
Completed
Not Applicable

The Evaluation of a New Sleep/Wake State Algorithm

ResMed1 site in 1 country36 target enrollmentNovember 2013
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
ResMed
Enrollment
36
Locations
1
Primary Endpoint
Total sleep time
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
February 2014
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ResMed
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Total sleep time

Time Frame: 12 hrs

To measure the total sleep time recorded and analysed on the device using the new algorithm

Secondary Outcomes

  • Frequency of arousals during sleep(12 hrs)
  • Duration of arousals during sleep(12 hrs)
  • Occurrence of arousals during sleep(12 hrs)

Study Sites (1)

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