Evaluation of Compumedics "Somfit" Device

Completed

• Conditions: Sleep Apnea
• Interventions: Device: Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)

• Registration Number: NCT04326127
• Lead Sponsor: Compumedics Limited

Brief Summary

To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.

Detailed Description

Sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and sleep). Poor quality and fragmented sleep leads to an increase in the risk for development of chronic health conditions. Given the importance of good quality sleep and its critical role in overall well-being, there is a need for regular monitoring and assessment of sleep quality in individuals. However, current technologies will only allow for this to be performed in sleep clinics and with the help of full polysomnography (PSG) systems which require the patients to spend a night at the clinic with several wired electrodes connected to their scalp. This will cause discomfort for the patients in a long run. To solve this problem, Compumedics has recently developed a miniaturized, portable and affordable sleep monitoring system with code name of "Somfit" which can be used in the comfort of patients' home. The aim of this study is to validate Somfit for home based sleep studies.

Study Timeline

• Study Start: 2019-11-06
• Primary Completion: 2019-11-19
• Study Completion: 2019-11-19
• Status Verified: 2020-03
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Last Update Submitted: 2020-03-28
• Study First Posted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Individuals age between 18 to 75
• Be able to give informed consent
• Individuals with diagnosed Obstructive Sleep Apnoea (OSA)

Exclusion Criteria

• Less than 18 years of age
• Greater than 75 years of age
• Unable or not willing to provide informed consent
• Need for nursing care
• Currently working nightshift

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)	Volunteers with diagnosed sleep apnea
Control	Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)	Healthy volunteers

Primary Outcome Measures

Name	Time	Method
Comparison between raw EEG signals	single night recording for each subject	Direct comparison of Raw EEG data between Somfit and Grael system on an epoch by epoch basis (with each epoch being equivalent to 30 secs) to test and validate Somfit for data acquisition, display and record of Raw EEG data.

Secondary Outcome Measures

Name	Time	Method
Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram	single night recording for each subject	Epoch-by-epoch comparison between manual and automatic scoring of sleep data recorded by Somfit and Grael devices

Trial Locations

Locations (1)

SleepMetrics Pty Ltd; 🇦🇺 Melbourne, Victoria, Australia