Prodigy, a Level 2 Sleep Study Device, Validation Study

Validation of a Level 2 Sleep Study Device

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea

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 Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8P 4M3
      • Hamilton Sleep Disorders Clinic
• United States
  • New York
    • Port Jefferson, New York, United States, 11777
      • St Charles Sleep Disorders Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from patients referred to either sleep clinic to undergo a diagnostic sleep test.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cerebra Medical
• Investigators: Principal Investigator: Amy Bender, PhD, Cerebra Medical; Principal Investigator: Raymond Gottschalk, MD, Hamilton Sleep Disorders Clinic; Principal Investigator: Mohammad Amin, MD, St Charles Sleep Disorders Center

Publications and helpful links

General Publications

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
• Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
• Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9. doi: 10.1093/sleep/32.7.915.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): April 9, 2022
• Study Completion (Actual): April 9, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Prodigy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: ProdigyValidationStudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No