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.

开始日期2023-08-01

申办/合作机构

Cerebra Health, Inc.初创企业

[+1]

NCT05237037 / RecruitingN/A

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.

开始日期2022-08-22

申办/合作机构

Cerebra Health, Inc.初创企业

NCT05115305 / CompletedN/A

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.

开始日期2022-01-14

申办/合作机构

Cerebra Health, Inc.初创企业

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2022-05-25·Sleep

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

作者: 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

2019-08-15·Journal of Clinical Sleep Medicine3区 · 医学

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

3区 · 医学

Article

作者: 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.

2018-04-27·Sleep

0317 Normal Values and Repeatability of a Novel Sleep Depth Scale; The Odds Ratio Product

作者: Gerardy, B ; Williams, M ; Penner, C

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2022-12-09

·Business Wire

Innovations and Growth Opportunities in Microfluidics, Point of Care Diagnostics and Digital Health: Including Microfluidic-Based Point-Of-Care Diagnostics, Diagnostic Biochips & More - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Innovations and Growth Opportunities in Microfluidics, Point of Care Diagnostics and Digital Health" report has been added to ResearchAndMarkets.com's offering. The latest issue of Advanced MedTech Technology Opportunity Engine (TOE) profiles a wide range of innovations from the advanced medical device and imaging industry. The issue includes advanced diagnostic technologies such as microfluidic-based point-of-care diagnostics, diagnostic biochips, AI-enabled breast cancer, and stroke diagnosis, genomic test for melanoma, or sticker based pediatric cystic fibrosis diagnosis. Some of the advanced medical device technologies such as nano-pulse stimulation technology, retinal prosthesis system, dry powder nebulizer, and nanotechnology-based blood purification system have been covered in this issue. Digital health solutions such as digital therapeutics for chronic condition management, digital colposcope, and AI in imaging are also included in this issue. These innovations portray the diversity in their technology readiness levels, indicating an immediate or potential market impact. The growth opportunities for all these advanced medical device technologies are also covered in this issue. The Advanced MedTech TOE analyzes and reports new and emerging technologies; advances in R&D, product development, and regulatory matters specifically related to the areas of wearables, implantables, diagnostics, surgical tools and instrumentation, image-guided surgery, drug delivery, patient monitoring, digital health, and medical imaging. Medical devices and imaging technology and innovation research cover cutting-edge global developments in medical devices and imaging sectors such as biosensors, biomaterials, biomechanics, microtechnologies, nanotechnologies, assistive technologies, and imaging technologies and platforms. Medical devices and imaging technology and innovation research cover cutting-edge global developments in medical devices and imaging sectors such as biosensors, biomaterials, biomechanics, microtechnologies, nanotechnologies, assistive technologies, and imaging technologies and platforms. Medical devices and imaging technology and innovation research cover cutting-edge global developments in medical devices and imaging sectors such as biosensors, biomaterials, biomechanics, microtechnologies, nanotechnologies, assistive technologies, and imaging technologies and platforms. Key Topics Covered: 1. Innovations in Medical Devices and Imaging Thermoplastic Elastomer for Biomicrofluidic Devices Value Proposition of Eden Tech Eden Tech - Investor Dashboard Microfluidics-based Point-of-care (POC) Blood Coagulation Diagnostics Value Proposition of Enzyre Enzyre - Investor Dashboard Epigenetic Clock Technology for Health and Aging Measurement Value Proposition of FOXO Technologies FOXO Technologies - Investor Dashboard Non-invasive Genomic Analysis Test for Melanoma Value Proposition of Akonni Biosystems Akonni Biosystems - Investor Dashboard Microfluidic Protein Microarray-based Point-of-care Diagnostics Sanwa BioTech's Value Proposition Sanwa BioTech - Investor Dashboard High-fidelity Implantable Neural Probes Diagnostic Biochips' Value Proposition Diagnostic Biochips - Investor Dashboard Indoor Positioning Platform for Providing Seamless Navigation for Patients Pointr Limited's Value Proposition Pointr Limited - Investor Dashboard Digital Therapeutics Platform for Managing Chronic Conditions Sidekick Health's Value Proposition Sidekick Health - Investor Dashboard Wristband for Menopausal Hot Flashes Management Embr Labs Inc.'s Value Proposition Embr Labs Inc. - Investor Dashboard Nano-pulse Stimulation Technology for Treating Benign Lesions Pulse Biosciences Inc.'s Value Proposition Pulse Biosciences Inc. - Investor Dashboard Digital Therapeutic Platform Treating Chronic Fecal Incontinence in Women Renovia - Value Proposition Renovia - Investor Dashboard Retinal Prostheses System for Providing Artificial Vision to Patients Pixium Vision - Value Proposition Pixium Vision - Investor Dashboard Digital Colposcope for Point-of-Care Cervical Cancer Detection Biop Medical's Value Proposition Biop Medical - Investor Dashboard Artificial Intelligence (AI)-powered Software for Early Diagnosis of Stroke Cerebra AI's Value Proposition Cerebra AI - Investor Dashboard Dry Powder Nebulizer for Lower Respiratory Tract Infection Treatment NHT's Value Proposition NHT - Investor Dashboard Nanotechnology-based Blood Purification System for Toxin Removal hemotune's Value Proposition hemotune - Investor Dashboard Digital Pain Drawing Software to Quantify and Analyze Pain Distribution in Patients University of Thessaly - Value Proposition AI System for Improving Accuracy of Breast Cancer Diagnosis in Ultrasound Images New York University Abu Dhabi - Value Proposition 2. Key Contacts 3. Appendix Criteria for Rating of Innovations - Explanation Legal Disclaimer Companies Mentioned Akonni Biosystems Biop Medical Cerebra AI Diagnostic Biochips Eden Tech Embr Labs Inc Enzyre FOXO Technologies hemotune New York University Abu Dhabi NHT Pixium Vision Pointr Limited Pulse Biosciences Inc Renovia Sanwa BioTech Sidekick Health University of Thessaly For more information about this report visit https://www.researchandmarkets.com/r/qh8hfe

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