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OpenTrials
Completed

NCT Number: NCT01925430

The Evaluation of a New Sleep 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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RedMed Ltd

Sydney, New South Wales, 2153, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening device

Device

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

Other names: ApneaLink, Actigraphy

Comparative product

Device

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

Other names: Actiwatch 2 (Respironics), Patient data recorder, Actigraphy

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

The Evaluation of a New Sleep/Wake State Algorithm

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 19, 2013
Registry last updated
May 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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