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David H. Winslow, M.D., F.C.C.P.
David H. Winslow, MD

David H. Winslow, M.D., F.C.C.P.
Diplomat American Board of Sleep Medicine

Chest Medicine Associates/Sleep Medicine Specialists/Kentucky Research Group
1169 Eastern Parkway, Sts 2266, 3310, 3311, & 3357
Louisville, KY 40217
July 1979 - Present

Personal

Birthdate: February 3, 1947
Married, wife Rita
Two children; Darran and Brian

Professional Training

University of Cincinnati Medical Center
Cincinnati, Ohio
Internship, Medical Rotating
June 1973-June-1974

University Hospital
Louisville, Kentucky
Residency in Medicine
July 1974-June 1976

University of Louisville Medical Center
Louisville, Kentucky
Fellowship in Pulmonary Diseases
July 1976 - June 1978

Education

University of Louisville
Louisville, Kentucky
Medical Doctor, June 1973

Murray State University
Murray, Kentucky
Bachelor of Science in Biology, Chemistry
Graduated August 1969

Licensing

Kentucky Medical License: No. 17414
American Board of Internal Medicine- June 1977
American Board of Internal Medicine in Pulmonary Diseases- June 1979
American Sleep Disorders Association Board Certified- Diplomate- June 1988

Medical Societies

Member American Thoracic Society
Member American Medical Association
Member Kentucky Thoracic Society
Member Kentucky Medical Association
Member Jefferson County Medical Society
Member Kentucky Sleep Society
Fellow American College of Chest Physicians
Fellow American College of Physicians
Fellow American Academy of Sleep Medicine

Faculty Positions

Associate Clinical Professor
Department of Medicine
University on Louisville School of Medicine

Directorships

Medical Director, Sleep Disorders Center
Norton Audubon Hospital
1983-Present

Medical Director, Chest Medicine Associates, DBA Sleep Medicine Specialists
1996-Present

Medical Director, Chest Medicine Associates, DBA Sleep Medicine Specialists
Research Division
1999-Present

Medical Director and President, Kentucky Research Group
2005-Present

Teaching

Residency Training Program
Norton Audubon Hospital
1984-Present

Professional Service

Medical Director
Louisville Narcolepsy Association
1984-Present

Norton Audubon Hospital
Chairman- Ethics Committee
1998-Present

Kentucky Sleep Society
Board Member
1998-Present
President 2001

Training

"Investigator Training for Medical Research"
Sponsored by: University of Rochester, School of Medicine & Dentistry
Strong Memorial Hospital
Western Institutional Review Board
Chicago, Illinois
August 31, 2001

Research

Pharmaceutical research, Principle Investigator:

Merck: A Double-Blind, Parallel, Placebo-Controlled, Multicenter, Polysomnographic Study of the Effects of L-759274 and Zolpidem in Patients with Chronic Insomnia. 1999.

Sepracor 190-046: A Randomized Double-Blind, Placebo-Controlled Parallel Study of the Efficacy and Safety of (S)-Zopiclone in the Treatment of Adult Subjects with Primary Insomnia. 2001.

Sepracor 190-047: A Randomized, Double-Blind, Placebo-Controlled Parallel, Two-Week Objective Efficacy and Safety Study of Esopiclone in Elderly Subjects with Primary Insomnia. 2001-2002.

Takeda 375-005: An Efficacy, Safety, and Dose Response Study of TAK-375 in Subjects with Chronic Insomnia. 2001-2002.

GlaxoSmithKline 101468/191: A 12 Week, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS). 2002.

Sanofi-Synthelabo EFC4529: Comparison of efficacy and safety of Zolpidem-MR 12.5mg and placebo in patients with primary insomnia. A double-blind, randomized, placebo controlled, parallel group study. 2002.

Neurocrine NBI34060-MR-0212: A phase III, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to assess the efficacy and safety of a modified release formulation of NBI-34060 in elderly primary insomnia patients with sleep maintenance difficulties. 2003.

Takeda 375-022: A phase III, Open-label, fixed dose study to determine the safety of long term administration of TAK-375 in subjects with chronic Insomnia. 2002.

GlaxoSmithKline 101468/243: A 52 Week, Open-label extension study of the Long-term safety and tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS). 2003.

Orphan Medical, Inc. OMC-SXB-15: A Randomized, double blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Zyrem (sodium oxybate) with Placebo for the Treatment of Narcolepsy. 2003.

Orphan Medical, Inc. OMC-SXB-19: An Open Label, Multi-Center Safety Trial studying the Effects of Orally Administered Xyrem (sodium oxybate). 2003.

Orphan Medical, Inc. OMC-SXB-22: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (sodium oxybate) and Modafinil with Placebo in the Treatment of Daytime Sleepiness in Narcolepsy. 2003 - 2004.

Takeda 01-03-TL-375-038: A Phase II Safety Study of TAK-375 in Subjects with Mild to Moderate Chronic Obstructive Pulmonary Disease. 2003.

GlaxoSmithKline 101468/249: A 12 Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). 2003-2004.

Sanofi-Synthelabo EFC5202: Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients with Primary Insomnia. A Double-Blind, Randomized, Placebo- Controlled, Three Way Cross-Over Study. 2003.

Altana Pharma BY217/M2-023: A Randomized, Controlled Study of Roflumilast (250 mcg and 500 mcg) Versus Placebo in Patients with Asthma. A 24-week, multicenter, multinational, double-blind, parallel group clinical study. 2004

Cephalon Inc., CEP-10953 C10953/3021/AP/MN: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 and 250 mg/day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome. 2004

Cephalon, Inc. C10953/3024/ES/MN:A 12-Month, Open-Label, Flexible- Dosage (100 to 250 mg/day) Extension Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder. 2004-Ongoing.

Aventis M100907C/2004: A North American, 4-Week, Multicenter, Phase IIB Double-Blind, Placebo-Controlled, Randomized, Multiple Dose, Parallel- Group Study of the Efficacy and Safety of 0.5 mg, 1.0 mg, and 2.0 mg M100907 Tablets in the treatment of Sleep Maintenance Insomnia. 2004-2005.

Sanofi-Synthelabo LTE5407: Evaluation of the Long-Term Efficacy and Safety of Zolpidem-MR 12.5mg Compared to Placebo, When Both are Administered Over a Long-Term Period "As Needed", in Patients With Chronic Primary Insomnia. (A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multicenter, Phase IIIb Clinical Study). 2004

Pfizer A9001243: A Study To Define The Non-Restorative Sleep Population. 2004 - 2005

Merck 002-00: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-night Polysomnographic Study of MK-0928 in Elderly Patients with Primary Insomnia. 2004-Ongoing.

Merck 004-00: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-night Polysomnographic Study of MK-0928 in Adult Patients with Primary Insomnia. 2004-Ongoing.

Oscient OS-001/FORCE: A Phase IV, Stratified, Randomized, Prospective, Unblinded, Active-control Trial of Factive Versus Biaxin XL for the Treatment of Community-aquired Pneumonia and Versus Amoxicillin/clavulante for the Treatment of Acute Bacterial Exacerbation of Chronic Bronchitis, and any subsequent amendments provided by Sponsor. 2004-Ongoing.

GlaxoSmithKline 100013: A 12 Week, Double-Blind, Placebo Controlled, Twice Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage. 2004

Takeda 01-04-TL-375-041: A Randomized, Double-Blind, Placebo Controlled Study to Assess the Subjective Response to Treatment With Ramelton (TAK-375) in Adult Subjects With Chronic Insomnia by Utilizing an Interactive Voice Response System (IVRS) for Collecting Diary Data. 2005

Neurocrine NBI-34060-MR-0501: A Phase III, Randomized, Double-Blind, Placebo Controlled, Polysomnographic Study to Assess the Efficacy and Safety of a Modified Release Formulation of NBI-34060 in Primary Insomnia Patients with Sleep Maintenance Difficulties. 2005

Somaxon SP-0501: A Phase III, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of Doxepin HCI in Primary Insomnia Patients with Sleep Maintenance Difficulties. 2005

Schwarz SP792: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome. 2005-Ongoing.

Kyowa 6002-US-201: A Phase 2, Double-Blind, Placebo Controlled, Randomized Parallel-Group, Multicenter Study to Evaluates the Efficacy and Safety of 40mg/day KW-6002 (Istradefylline) in Subjects with Restless Legs Syndrome. 2005-Ongoing

GlaxoSmithKline 1001468/205: A 12 Week, Double-Blind, Placebo-Controlled, Parallel-Group Study yo Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients With Restless Legs Syndrome. 2005

Somaxon SP-0503: A Phase III, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Assess the Long Term Efficacy and Safety of Doxepin HCI in Primary Elderly Insomnia Patients with Sleep Maintenance Difficulties. 2005-Ongoing.

Takeda EC302: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia. 2005 - Ongoing.

Cephalon C10953/3046/ES/US: A Short-Term (8-Week) Open-Label Study, Followed by a Long-Term Evaluation, to Assess Patient Reported Outcomes with Armodafinil Treatment (150 to 250 mg/day) For Excessive Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS). 2005-Ongoing.

Sanofi-Aventis LTE6262: Efficacy and Safety of Eplivanserin 5mg/day on Sleep Maintenance Insomnia: a 12-Week multicenter, Randomized, Double-Blind, Placebo-Controlled Study Followed by an open Treatment Phase Extension with Eplivanserin for a 40 Week Period. 2006-Ongoing.

XenoPort, Inc. XP052: A Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients with Restless Legs Syndrome. 2006-Ongoing.

Schwarz SP793: An Open-Label Extension Trial to Investigate the Safety and Tolerability of Long-Term Treatment with Transdermal Rotigotine in Subjects with Idiopathic Restless Legs Syndrome. 2006 - Ongoing.

Merck 022: A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidimia. 2006-Ongoing.

Merck 024: A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of MK-0524B Verses Atorvastatin in Patients With Mixed Hyperlipidemia. 2006 - Ongoing.

Publications

Carloss, H., Winslow, D., Kastan, L. and Yam, L. T. Bone marrow necrosis. Archives of Internal Medicine 137: 863-866, 1977.

Winslow, D. H. Exercise induced asthma. Journal of the Kentucky Medical Association 76: 271-274, 1978.

Browman, C. P. and Winslow, D. H. Sleep apnea syndrome. Louisville Medicine 31: 19-21, September 1983.

Browman, C. P. and Winslow, D. H. Insomnia and family practice. Kentucky Academy of Family Physicians Journal 29: 14-15, October, 1983.

Giradet, R. E., Goodin, R. R., Johnson, S. G., Shanahan, P.T., Melo, J. C., Winslow, D. H., Woo, D., Epstein, W. M., Watson, K., Steltzer, G., Burke, G., Rhine, G., Lansing, A. Heart transplantation at the Humana Heart Institute International. Journal of the Kentucky Medical Association 84: 261 - 267, 1986.

Browman, C. P. and Winslow, D. H. Clinical aspects of insomnia. Comprehensive Therapy, 12: 29 - 35, October 1986.

Dogramji, K., Breuninger, W. M., Browman, C. P., Gaddy, J. R., Muehlbach, M. J., Schweitzer, P. K., Walsh, J. K., and Winslow, D. H. Triazolam treatment of periodic leg movements during sleep. Sleep Research 17:38, 1988

Browman, C. P. and Winslow, D. H. Determination of sleep latency in polysomnographic evaluations of daytime somnolence in patients with sleep apnea and patients with narcolepsy. Clinical Electroencephalography 20: 45 - 48, 1989.

Browman, C. P., Newman, J. C., and Winslow, D. H. Nasal CPAP therapy for obstructive sleep apnea syndrome: Determinants of long-term compliance. Sleep Research 18: 206, 1989.

Browman, C. P., Unruh, M. M., and Winslow, D. H. Differential diagnosis of the hypersomnolent patient. Sleep Research in press.

Browman, C. P., Ostrander, S. E., Starz, K. E., and Winslow, D. H. Effect of two formulations of triazolam in induced sleep-onset insomnia. Sleep Research 18: 47, 1989.

Browman, C. P., Winslow, D. H., Starz, K. E., Roehrs, T. A., Harris, A. E., Rosenthal, L. D., and Roth, T. Effects of triazolam, a new formulation of triazolam, and placebo on the sleep of patients with chronic insomnia. Sleep Research 18: 48, 1989.

App, W. E., Boatwright, G. W., Ostrander, S. E., Unruh, M. M., and Winslow, D. H. Disorder of excessive daytime somnolence: A case series of 1,000 patients. Journal of the Kentucky Medical Association 88: 393 396, 1990.

Newman, J. C., Unruh, M. M., and Winslow, D. H. Nasal CPAP Therapy for Obstructive Sleep Apnea Syndrome: Determinants of Long Term Compliance. 1989 Annual Meeting Abstracts, Association of Professional Sleep Societies, 3rd Annual Meeting. June 1989.

Winslow, D. H. Sleep Hypopnea Syndrome. 1990 Annual Meeting Abstracts, Kentucky Thoracic Society Scientific Conference on Pulmonary Disease, March 1990.

Winslow, D. H. Cocaine Abuse Presented as Narcolepsy. 1990 Annual Meeting Abstracts, Kentucky Thoracic Society Scientific Conference on Pulmonary Disease, March 1990.

Winslow, D. H. Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome. Sleep Journal of Sleep and Sleep Disorders Research August 2004;27:907-914

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