The Evaluation of a New Sleep Algorithm

Healthy Clinical Trial

Official title:

The Evaluation of a New Sleep/Wake State Algorithm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925430
• Other study ID #: MA06082013
• Status: Completed
• Phase: N/A
• First received: August 15, 2013
• Last updated: May 1, 2014
• Start date: November 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Screening device
Non-invasive device worn over clothes during sleep. Used to screen for sleep-disordered breathing conditions.
• Comparative product
A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states

Locations

Country	Name	City	State
Australia	RedMed Ltd	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sleep time	To measure the total sleep time recorded and analysed on the device using the new algorithm	12 hrs	No
Secondary	Frequency of arousals during sleep	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	No
Secondary	Duration of arousals during sleep	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	No
Secondary	Occurrence of arousals during sleep	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	No