The Evaluation of a New Sleep Algorithm

Completed

• Conditions: Healthy
• Interventions: Device: Comparative product; Device: Screening device

• Registration Number: NCT01925430
• Lead Sponsor: ResMed

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-19
• Study Start: 2013-11
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-01
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Comparative product	Comparative product	A device which monitors sleep/wake states
Screening device	Screening device	This device will screen for sleep-breathing disorders

Primary Outcome Measures

Name	Time	Method
Total sleep time	12 hrs	To measure the total sleep time recorded and analysed on the device using the new algorithm

Secondary Outcome Measures

Name	Time	Method
Frequency of arousals during sleep	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
Duration of arousals during sleep	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
Occurrence of arousals during sleep	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

Trial Locations

Locations (1)

RedMed Ltd; 🇦🇺 Sydney, New South Wales, Australia