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The Evaluation of a New Sleep Algorithm

The Evaluation of a New Sleep/Wake State Algorithm

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01925430
Enrollment
36
Registered
2013-08-19
Start date
2013-11-30
Completion date
2014-02-28
Last updated
2014-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Observational, Sleep, Algorithm

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.

Interventions

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

DEVICEComparative product

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

Sponsors

ResMed
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total sleep time12 hrsTo measure the total sleep time recorded and analysed on the device using the new algorithm

Secondary

MeasureTime frameDescription
Frequency of arousals during sleep12 hrsTo compare the data acquired of the new device's algorithm against a pre-existing device detailing the frequency of sleep and wake periods
Duration of arousals during sleep12 hrsTo compare the data acquired of the new device's algorithm against a pre-existing device detailing the duration of sleep and wake
Occurrence of arousals during sleep12 hrsTo compare the data acquired of the new device's algorithm against a pre-existing device detailing when sleep and wake periods occurred

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026