Prodigy, a Level 2 Sleep Study Device, Validation Study

• Sponsor: Cerebra Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05115305
• Collaborator: (none)
• Enrollment: 84
• Locations: 2
• Actual Duration (Months): 2.8
• Patients Per Site: 42
• Patients Per Site Per Month: 15

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 84 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Validation of a Level 2 Sleep Study Device
• Actual Study Start Date: Jan 14, 2022
• Actual Primary Completion Date: Apr 9, 2022
• Actual Study Completion Date: Apr 9, 2022

Outcome Measures

Primary Outcome Measures

1. Total Sleep Time [Concurrent measurement for one night]

   To compare Level 1 and Level 2 sleep tests on TST

2. Apnea-Hypopnea Index [Concurrent measurement for one night]

   To compare Level 1 and Level 2 sleep tests on AHI

3. Periodic Limb Movement Index [Concurrent measurement for one night]

   To visually compare Level 1 and Level 2 sleep tests on PLM

Secondary Outcome Measures

1. Signal Quality [Concurrent measurement for one night]

   To compare signal quality between Level 1 and Level 2 sleep tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Charles Sleep Disorders Center	Port Jefferson	New York	United States	11777
2	Hamilton Sleep Disorders Clinic	Hamilton	Ontario	Canada	L8P 4M3

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5.
• 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.
• Morin CM, Belleville G, Bélanger 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.

• Responsible Party: Cerebra Medical
• ClinicalTrials.gov Identifier: NCT05115305
• Other Study ID Numbers: ProdigyValidationStudy
• First Posted: Nov 10, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cerebra Medical: Prodigy
• Additional relevant MeSH terms: Sleep Apnea Syndromes

Study Results

No Results Posted as of Jul 20, 2022