Evaluation of Compumedics "Somfit" Device

Performance Evaluation of the Compumedics "Somfit" Sleep Monitoring Device

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

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: 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)

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3752
      • SleepMetrics Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

30 volunteers were invited to participate in this study. 15 participants will be selected among healthy volunteers, by advertising to the general public. The remaining 15 will be among patients with diagnosed sleep apnea who visit SleepMetrics clinic as part of their routine treatment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Healthy volunteers	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
Case; Volunteers with diagnosed sleep apnea	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of the new device for detection of sleep apnea	Differentiation between case and control groups	single night recording for each subject

Collaborators and Investigators

• Sponsor: Compumedics Limited
• Investigators: Principal Investigator: Elizabeth Kealy, Sleepmetrics

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): November 19, 2019
• Study Completion (Actual): November 19, 2019

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 28, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: SOMFIT02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No