Evaluation of Compumedics "Somfit" Device
NCT04326127 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2020-03-31
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.
Conditions
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)
Data were recorded overnight by both devices simultaneously
Sponsors & Collaborators
-
Compumedics Limited
lead INDUSTRY
Principal Investigators
-
Elizabeth Kealy · Sleepmetrics
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-11-06
- Primary Completion
- 2019-11-19
- Completion
- 2019-11-19
Countries
- Australia
Study Locations
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