Comparative Assessment of Compumedics Somfit Sleep Monitoring Device
NCT05647746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2024-02-07
Summary
To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing
Conditions
- Sleep-Disordered Breathing
Interventions
- DEVICE
-
Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system
Each intervention is a separate diagnostic device. They will all be operating at the same time
Sponsors & Collaborators
-
Compumedics Limited
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-10
- Primary Completion
- 2023-02-28
- Completion
- 2023-05-31
Countries
- Australia
Study Locations
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