The perioperative management of surgery patients can be seriously complicated by Sleep Disordered Breathing (SDB). Anesthetics can suppress the Central Nervous System (CNS), reduce pharyngeal muscle tone and depress respiratory drive, which promote airway occlusion in SDB patients. Numerous research including a new guideline circulated in draft form by the American Society of Anesthesiologists is promoting careful management of SDB patients including preoperative sleep evaluation. Despite its significance, sleep disorders diagnosis is not done before surgeries. While testing can be done in the lab, sleep evaluation of hospitalized patients is best done in their hospital room because it is more comfortable to them and does not interrupt planned cardiac care. Other reasons include lack of sleep facilities in a significant number of hospitals, scheduling and cost (will be evaluated in this proposal). ? ? This proposal will complete the development of a novel telemetry sleep monitor (Crystal 20-H) that will allow attended polysomnography (PSG) to occur in any hospital room at any time. The system, based on previous SBIR Phase II technology, is small and wireless with software and hardware specifically designed for this application; it will transmit PSG data from the patient's room to a nurse's station and to a sleep lab (if available) many floors away. We will demonstrate device safety and efficacy by conducting a large prospective evaluation on 400 cardiovascular surgery patients pre-operatively at the Cleveland Clinic Foundation and Johns Hopkins University, which we believe has never been done previously. Important study outcomes include demonstrating superior performance over current methods (sleep assessment questionnaires), and quantifying SDB prevalence and morbidity in that population. Cost effectiveness of sleep evaluation in that setting will be determined. We will also obtain FDA approval. In addition to demonstrating device effectiveness in this application, the powerful results from this proposal will raise the awareness level for this emerging unmet clinical need and will encourage hospitals to include in their pre-surgical protocols inpatient PSG assessment for at risk patients. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44NS042451-06
Application #
7500192
Study Section
Special Emphasis Panel (ZRG1-RES-A (10))
Program Officer
Mitler, Merrill
Project Start
2002-09-30
Project End
2010-07-31
Budget Start
2008-09-30
Budget End
2010-07-31
Support Year
6
Fiscal Year
2008
Total Cost
$908,367
Indirect Cost
Name
Cleveland Medical Devices, Inc.
Department
Type
DUNS #
557510625
City
Cleveland
State
OH
Country
United States
Zip Code
44103
Foldvary-Schaefer, Nancy; Kaw, Roop; Collop, Nancy et al. (2015) Prevalence of Undetected Sleep Apnea in Patients Undergoing Cardiovascular Surgery and Impact on Postoperative Outcomes. J Clin Sleep Med 11:1083-9
Kaw, Roop; Gali, Bhargavi; Collop, Nancy A (2011) Perioperative care of patients with obstructive sleep apnea. Curr Treat Options Neurol 13:496-507