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

  • Australia
    • 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
Device: Comparative product
A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states
Other Names:
  • Actigraphy
  • Actiwatch 2 (Respironics)
  • Patient data recorder
Screening device
This device will screen for sleep-breathing disorders
Device: Screening device
Non-invasive device worn over clothes during sleep. Used to screen for sleep-disordered breathing conditions.
Other Names:
  • ApneaLink
  • Actigraphy

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

ResMed

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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