Prodigy, a Level 2 Sleep Study Device, Validation Study

Completed

• Conditions: Sleep Apnea

• Registration Number: NCT05115305
• Lead Sponsor: Cerebra Medical

Brief Summary

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.

Detailed Description

This study consists of obtaining standard polysomnography signals concurrently by the Prodigy 2 and by the standard commercial systems used in the Sleep Disorders Clinic (Alice G3) in Hamilton, ON and the St. Charles Sleep Disorders Center (Nihon Kohden) in Port Jefferson, NY. 42 patients will be recruited from each of the two sites, for a total of 84 patients. Questionnaires on demographics and mental health, including the Depression Anxiety Stress Scale-21, questionnaires on sleep and fatigue including Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Epworth Sleepiness Scale and questionnaires on quality of life including the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) and the Euroquol 5D-5L will be completed online using a survey platform (Qualtrics or RedCap).

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-10
• Study Start: 2022-01-14
• Primary Completion: 2022-04-09
• Study Completion: 2022-04-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• patients undergoing a diagnostic sleep test

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Sleep Time	Concurrent measurement for one night	To compare Level 1 and Level 2 sleep tests on TST
Apnea-Hypopnea Index	Concurrent measurement for one night	To compare Level 1 and Level 2 sleep tests on AHI
Periodic Limb Movement Index	Concurrent measurement for one night	To visually compare Level 1 and Level 2 sleep tests on PLM

Secondary Outcome Measures

Name	Time	Method
Signal Quality	Concurrent measurement for one night	To compare signal quality between Level 1 and Level 2 sleep tests

Trial Locations

Locations (2)

St Charles Sleep Disorders Center; 🇺🇸 Port Jefferson, New York, United States

Hamilton Sleep Disorders Clinic; 🇨🇦 Hamilton, Ontario, Canada