Prodigy, a Level 2 Sleep Study Device, Validation Study

Validation of a Level 2 Sleep Study Device

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05115305

Enrollment

Registered

2021-11-10

Start date

2022-01-14

Completion date

2022-04-09

Last updated

2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

Prodigy

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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
Total Sleep Time	Concurrent measurement for one night	To compare Level 1 and Level 2 sleep tests on TST

Secondary

Measure	Time frame	Description
Signal Quality	Concurrent measurement for one night	To compare signal quality between Level 1 and Level 2 sleep tests

Countries

Canada, United States

Outcome results