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Completed

NCT Number: NCT05115305

Prodigy, a Level 2 Sleep Study Device, Validation Study

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Sleep Disorders Clinic, Hamilton, Ontario, Canada

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About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Total Sleep Time

    Time frame: Concurrent measurement for one night

    To compare Level 1 and Level 2 sleep tests on TST

  2. Apnea-Hypopnea Index

    Time frame: Concurrent measurement for one night

    To compare Level 1 and Level 2 sleep tests on AHI

  3. Periodic Limb Movement Index

    Time frame: Concurrent measurement for one night

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

Secondary outcomes

  1. Signal Quality

    Time frame: Concurrent measurement for one night

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

Sponsors and collaborators

Lead sponsor

Cerebra Medical

Industry

Registry information

Official study title

Validation of a Level 2 Sleep Study Device

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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