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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.
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).
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Signal Quality | To compare signal quality between Level 1 and Level 2 sleep tests | Concurrent measurement for one night |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from patients referred to either sleep clinic to undergo a diagnostic sleep test.
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| Name | Affiliation | Role |
|---|---|---|
| Amy Bender, PhD | Cerebra Medical | Principal Investigator |
| Raymond Gottschalk, MD | Hamilton Sleep Disorders Clinic | Principal Investigator |
| Mohammad Amin, MD | St Charles Sleep Disorders Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Charles Sleep Disorders Center | Port Jefferson | New York | 11777 | United States | ||
| Hamilton Sleep Disorders Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7726811 | Background | 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. | |
| 2748771 | Background | 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. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Hamilton |
| Ontario |
| L8P 4M3 |
| Canada |
| 21532953 | Background | 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. |
| 1798888 | Background | 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. |
| 19639754 | Background | 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. |
| 21479777 | Background | 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. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |