Clinical trial NCT05115305: Prodigy, a Level 2 Sleep Study Device, Validation Study
Official title: Validation of a Level 2 Sleep Study Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Keywords: Prodigy
Lead sponsor: Cerebra Medical
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from patients referred to either sleep clinic to undergo a diagnostic sleep test.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Total Sleep Time
timeFrame: Concurrent measurement for one night
measure: Apnea-Hypopnea Index
timeFrame: Concurrent measurement for one night
measure: Periodic Limb Movement Index
timeFrame: Concurrent measurement for one night
Secondary outcomes:
measure: Signal Quality
timeFrame: Concurrent measurement for one night
Other outcomes:
Locations:
city: Port Jefferson
country: United States
facility: St Charles Sleep Disorders Center
state: New York
city: Hamilton
country: Canada
facility: Hamilton Sleep Disorders Clinic
state: Ontario
Study officials:
affiliation: Cerebra Medical
name: Amy Bender, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Sleep Disorders Clinic
name: Raymond Gottschalk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Charles Sleep Disorders Center
name: Mohammad Amin, MD
role: PRINCIPAL_INVESTIGATOR
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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. doi: 10.1093/sleep/32.7.915.
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