The Evaluation of a New Sleep Algorithm

NCT ID: NCT01925430

Last Updated: 2014-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Comparative product

A device which monitors sleep/wake states

Comparative product

Intervention Type DEVICE

A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states

Screening device

This device will screen for sleep-breathing disorders

Screening device

Intervention Type DEVICE

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

Interventions

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Screening device

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

Intervention Type DEVICE

Comparative product

A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states

Intervention Type DEVICE

Other Intervention Names

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ApneaLink Actigraphy Actiwatch 2 (Respironics) Patient data recorder Actigraphy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus Schindhelm, BE PhD

Role: PRINCIPAL_INVESTIGATOR

The University of New South Wales, Australia & ResMed Ltd

Locations

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RedMed Ltd

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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MA06082013

Identifier Type: -

Identifier Source: org_study_id

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