Randomized Control Trial to Compare Patient Outcomes Following Unattended Polysomnography Versus In-lab Polysomnography for Sleep Apnea and Comorbid Sleep Disorders

This randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and sleep-related movement disorders, provides similar patient outcomes when compared to level 1 sleep studies.

Start Date01 Aug 2023

Sponsor / Collaborator

Cerebra Health, Inc.Startup

[+1]

NCT05237037

/ RecruitingNot Applicable

Assessment of Sleep Quality in Patients Utilizing Cannabinoid Therapy

The current study aims to assess the impact of starting cannabinoid therapy on sleep quality for individuals with sleep disturbance.

Start Date22 Aug 2022

Sponsor / Collaborator

Cerebra Health, Inc.Startup

NCT05115305

/ CompletedNot Applicable

Validation of a Level 2 Sleep Study Device

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.

Start Date14 Jan 2022

Sponsor / Collaborator

Cerebra Health, Inc.Startup

100 Clinical Results associated with Cerebra Health, Inc.

0 Patents (Medical) associated with Cerebra Health, Inc.

Literatures (Medical) associated with Cerebra Health, Inc.

25 May 2022·Sleep

0606 A Paradigm for Testing the Accuracy of Digital Sleep Staging Systems

Author: Younes, Magdy ; Pack, Allan ; Kuna, Samuel ; Tomson, Heather ; Gerardy, Bethany ; Walsh, James ; Kushida, Clete

AbstractIntroductionDespite evidence showing that agreement between human and some automatic staging systems is generally comparable to agreement between human scorers, automated scoring is rarely used in clinical practice, even though it offers time savings and consistency. We propose a paradigm for testing digital systems that reveals their true accuracy vs. highly experienced academic scorers. As an example of a digital method to be tested, we used Michele Sleep Scoring (abbreviated:Digital).Methods70 PSGs were scored by 6 experienced technologists from 3 academic centers. Staging results were compared to digital staging results using an epoch-by-epoch approach. For each PSG we carried out 6 cycles of comparisons. Each cycle consisted of two steps, one comparing one scorer (tested scorer) with the scoring of the five remaining scorers (judges), and one comparing Digital as the tested scorer with the same 5 judges. Error 1 was assessed when all judges disagreed with the tested scorer but there was disagreement between the judges. Error 2 was assigned when all judges disagreed with the tested scorer but agreed unanimously on the stage. For each PSG the number of epochs with types 1 and 2 errors was counted for each scorer (n=6 scorers) and for Digital. Results of all 70 PSGs were pooled, and percent of types 1 and 2 errors is reported for all scorers and Digital.Results70 PSGs (females aged 51.1 ± 4.2 years) were evaluated. Average times in different sleep stages (manual scoring) were 43±18, 244±47, 30±21, and 81±25 minutes for stages N1, N2, N3 and REM, respectively. TST was 398±52 minutes, and sleep efficiency was 84±8%. There was a total of 65,053 epochs scored by each scorer and Digital. The average percent of type 1 errors made by scorers for all epochs was 6.4% (0-33.2) vs. 7.8% (1.68-26.6) made by Digital. The average percent of type 2 errors made by scorers for all epochs was 3.9% (0-28.6) vs. 4.3% (0-17.3) made by Digital.ConclusionThis study provides an objective way of testing the accuracy of automated scoring systems and supports evidence that the accuracy of Michele Sleep Scoring is comparable to manual scoring.Support (If Any)None

15 Aug 2019·Journal of Clinical Sleep MedicineQ3 · MEDICINE

The Odds Ratio Product (An Objective Sleep Depth Measure): Normal Values, Repeatability, and Change With CPAP in Patients With OSA

Q3 · MEDICINE

Article

Author: Ryan, Rob ; Williams, Mark ; Gerardy, Bethany ; Penner, Charles Gerhard

STUDY OBJECTIVESThe Odds Ratio Product (ORP) is an objective measure of sleep depth using the relationships of the powers of different electroencephalogram (EEG) frequencies in a single index. The range of the ORP is 0 (deeply asleep) to 2.5 (fully awake). This investigation seeks to elucidate normal values of non-rapid eye movement ORP (ORP_NR) in healthy individuals, repeatability of the measure, and the change in ORP_NR following continuous positive airway pressure (CPAP) treatment.METHODSHealthy individuals underwent a home sleep apnea test (HSAT) with EEG followed 1 week later by EEG alone. Another cohort with OSA underwent baseline HSAT with EEG followed by a second EEG study approximately 4 weeks into treatment with CPAP.RESULTSThirty-eight healthy individuals completed the protocol (mean age of 34.9 ± 7.4 years, Epworth Sleepiness Scale score 3.6 ± 2.4, Insomnia Severity Index score 2.0 ± 1.6 and Functional Outcomes of Sleep Questionnaire - shorter version score 19 ± 1.2). The mean ORP_NR for all nights was 0.52 ± 0.13. The difference between the first night and the second night was 0.024 ± 0.17 (not significant). The intraclass correlation coefficient was 0.525, suggesting only moderate agreement between the first and second nights. The normal value for ORP_NR in healthy individuals is ≤ 0.78 units using two standard deviations as the cutoff. Forty participants completed the OSA protocol (mean age 49 ± 11 years, body mass index 35 ± 6 kg/m², apnea-hypopnea index 33.5 ± 28.4 events/h). The mean pre-CPAP ORP_NR was 0.69 ± 0.24 and the mean post-CPAP ORP_NR was 0.57 ± 0.22 (P = .02).CONCLUSIONSThe ORP_NR proves to have significant variability from night to night in healthy individuals. ORP_NR objectively improves following CPAP treatment, providing further evidence that it measures sleep depth.CITATIONPenner CG, Gerardy B, Ryan R, Williams M. The odds ratio product (an objective sleep depth measure): normal values, repeatability, and change with CPAP in patients with OSA. J Clin Sleep Med. 2019;15(8):1155-1163.

27 Apr 2018·Sleep

0568 Objective Improvement in Sleep Depth and Quality Following Initiation of Continuous Positive Airway Pressure for Obstructive Sleep Apnea

Author: Gerardy, B ; Penner, C G ; Williams, M ; Ryan, R

100 Deals associated with Cerebra Health, Inc.

100 Translational Medicine associated with Cerebra Health, Inc.

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