Prodigy, a Level 2 Sleep Study Device, Validation Study

Cerebra Medical

Status: Completed

Conditions: Sleep Apnea

Study type: Observational

Funder types: Industry

Identifiers

NCT05115305

ProdigyValidationStudy

Details and patient eligibility

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.

Full 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).

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.