Evaluation of Compumedics "Somfit" Device

Sleep Apnea Clinical Trial

Official title:

Performance Evaluation of the Compumedics "Somfit" Sleep Monitoring Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326127
• Other study ID #: SOMFIT02
• Status: Completed
• Start date: November 6, 2019
• Est. completion date: November 19, 2019

Study information

• Verified date: March 2020
• Source: Compumedics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 19, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

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)
Data were recorded overnight by both devices simultaneously

Locations

Country	Name	City	State
Australia	SleepMetrics Pty Ltd	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Compumedics Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Validation of the new device for detection of sleep apnea	Differentiation between case and control groups	single night recording for each subject
Primary	Comparison between raw EEG signals	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.	single night recording for each subject
Secondary	Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram	Epoch-by-epoch comparison between manual and automatic scoring of sleep data recorded by Somfit and Grael devices	single night recording for each subject