SBIR-STTR Award

Oral Appliance Compliance & Efficacy (ACE) System
Award last edited on: 9/2/14

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$210,951
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Matthew D Tarler

Company Information

Cleveland Medical Devices Inc (AKA: Orbital Research Inc~CleveMed)

4415 Euclid Avenue Suite 400
Cleveland, OH 44103
   (877) 253-8363
   N/A
   www.clevemed.com
Location: Single
Congr. District: 11
County: Cuyahoga

Phase I

Contract Number: 1R43HL120421-01
Start Date: 9/1/13    Completed: 2/28/15
Phase I year
2013
Phase I Amount
$210,951
Obstructive Sleep Apnea (OSA) accounts for millions of people not getting adequate or restful sleep and result in loss of productivity, car accidents, and is recognized as a co-morbidity of COPD and other diseases. Snoring, a typical symptom of OSA is also a disruption to a sleeping partner with potentially similar clinical manifestations as the afflicted person themselves. One of the existing approved medical treatment options for snoring and mild to moderate OSA include oral appliances. Oral appliances offer many advantages over the traditional positive airway pressure (PAP) type of devices, including no noise, less physically annoying (to many), and ease of portability. However, oral appliances also lack the capabilities necessary for monitoring compliance and effectiveness that are needed to fulfill regulatory requirements and conduct population-based effectiveness research. The proposed work will design, develop and prototype a new system that will be incorporated into multiple oral appliances and will specifically monitor compliance and effectiveness. The phase I will successfully design, develop, and prototype a system that can be incorporated into the oral appliances. A phase II will develop and implement extended clinical protocols for testing and evaluating the clinical compliance and effectiveness of various oral appliances.

Public Health Relevance Statement:


Public Health Relevance:
Oral appliances are becoming a more accepted and utilized treatment for Obstructive Sleep Apnea, however, they lack the capabilities necessary for monitoring compliance and effectiveness that are needed to fulfill regulatory requirements and conduct population-based effectiveness research. This proposed work will design, develop and prototype a new system that will be incorporated into multiple oral appliances and will specifically monitor compliance and effectiveness in a non-obtrusive and without any significant increase in patient burden.

NIH Spending Category:
Behavioral and Social Science; Bioengineering; Clinical Research; Lung; Sleep Research

Project Terms:
Accidents; Accounting; base; Charge; Chronic Obstructive Airway Disease; Clinical; Clinical Protocols; Communication; Comorbidity; Compliance behavior; Coupling; Data; Data Analyses; design; Devices; Disease; Docking; Effectiveness; effectiveness research; Feedback; Head; Health Personnel; Hour; Life; Medical; Methods; Microprocessor; Monitor; monitoring device; Noise; Obstructive Sleep Apnea; Oral; Oral cavity; Patient Self-Report; Patients; Persons; Phase; Polysomnography; population based; portability; Positioning Attribute; pressure; productivity loss; prototype; public health relevance; Questionnaires; Reading; Reporting; Research; Respiration; sensor; Sleep; Snoring; success; Symptoms; System; Temperature; Testing; Time; treatment duration; Treatment Effectiveness; Treatment outcome; Variant; Wireless Technology; Work

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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