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Prodigy, a Level 2 Sleep Study Device, Validation Study

Sponsored by Cerebra Medical

About this trial

Last updated 3 years ago

Study ID

ProdigyValidationStudy

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 3 years ago

What is this trial about?

The Prodigy system, developed by Cerebra Medical Ltd, allows for the generation of the same information in the home that is currently only obtained in in-laboratory studies. The objective of the current study is to demonstrate that the signals obtained by this comprehensive, portable system are comparable to those obtained in in-laboratory studies.

What are the participation requirements?

Yes

Inclusion Criteria

- patients undergoing a diagnostic sleep test

No

Exclusion Criteria

- in-hospital patients

- subjects who self-report a previous diagnosis of neuromuscular disorders, obesity hypoventilation, or severe lung disease

- subjects who are not fluent in English, or who have special communication needs

- subjects who have dementia/Alzheimer's disease

- subjects with comorbid violent parasomnias

- subjects requiring additional assistance or who have limited ability follow commands.

Locations

Location

Status