Prodigy, a Level 2 Sleep Study Device, Validation Study

Completed

Conditions studied: Sleep Apnea

In brief

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.

Key facts

Study ID

NCT05115305

Run by

Cerebra Medical

People needed

84

Starts

2022-01-14

Expected to finish

2022-04-09

Last updated by the study team

2022-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients undergoing a diagnostic sleep test

You may not qualify if…

• 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.

Where it is running

• St Charles Sleep Disorders Center — Port Jefferson, New York, United States
• Hamilton Sleep Disorders Clinic — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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