Prodigy, a Level 2 Sleep Study Device, Validation Study

Sleep Apnea Clinical Trial

Official title:

Validation of a Level 2 Sleep Study Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05115305
• Other study ID #: ProdigyValidationStudy
• Status: Completed
• Start date: January 14, 2022
• Est. completion date: April 9, 2022

Study information

• Verified date: July 2022
• Source: Cerebra Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 9, 2022
• Est. primary completion date: April 9, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
Canada	Hamilton Sleep Disorders Clinic	Hamilton	Ontario
United States	St Charles Sleep Disorders Center	Port Jefferson	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cerebra Medical

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Sleep Time	To compare Level 1 and Level 2 sleep tests on TST	Concurrent measurement for one night
Primary	Apnea-Hypopnea Index	To compare Level 1 and Level 2 sleep tests on AHI	Concurrent measurement for one night
Primary	Periodic Limb Movement Index	To visually compare Level 1 and Level 2 sleep tests on PLM	Concurrent measurement for one night
Secondary	Signal Quality	To compare signal quality between Level 1 and Level 2 sleep tests	Concurrent measurement for one night