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OpenTrials
Completed

NCT Number: NCT04326127

Evaluation of Compumedics "Somfit" 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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SleepMetrics Pty Ltd

Melbourne, Victoria, 3752, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)

Device

Data were recorded overnight by both devices simultaneously

Primary outcomes

  1. Comparison between raw EEG signals

    Time frame: 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 outcomes

  1. Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram

    Time frame: single night recording for each subject

    Epoch-by-epoch comparison between manual and automatic scoring of sleep data recorded by Somfit and Grael devices

Other outcomes

  1. Validation of the new device for detection of sleep apnea

    Time frame: single night recording for each subject

    Differentiation between case and control groups

Sponsors and collaborators

Lead sponsor

Compumedics Limited

Industry

Registry information

Official study title

Performance Evaluation of the Compumedics "Somfit" Sleep Monitoring Device

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2020
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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