Status:
COMPLETED
Evaluation of Compumedics "Somfit" Device
Lead Sponsor:
Compumedics Limited
Conditions:
Sleep Apnea
Eligibility:
All Genders
18-75 years
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 con...
Eligibility Criteria
Inclusion
- Individuals age between 18 to 75
- Be able to give informed consent
- Individuals with diagnosed Obstructive Sleep Apnoea (OSA)
Exclusion
- 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
Key Trial Info
Start Date :
November 6 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 19 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04326127
Start Date
November 6 2019
End Date
November 19 2019
Last Update
March 31 2020
Active Locations (1)
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1
SleepMetrics Pty Ltd
Melbourne, Victoria, Australia, 3752