Study design considerations for sleep-disordered breathing devices

Author:

Mann Eric A.1,Nandkumar Srinivas1,Addy Nancy2,Demko B. Gail3,Freedman Neil S.4,Gillespie M. Boyd5,Headapohl William6,Kirsch Douglas B.7,Phillips Barbara A.8,Rosen Ilene M.9,Schneider Logan D.10,Stepnowsky Carl J.6,Yaremchuk Kathleen L.11,Eydelman Malvina B.1

Affiliation:

1. Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland;

2. American Academy of Dental Sleep Medicine, Lisle, Illinois;

3. Sleep Apnea Dentists of New England, Weston, Massachusetts;

4. Division of Pulmonary, Critical Care, Allergy and Immunology, Northshore University Health System, Evanston, Illinois;

5. Department of Otolaryngology–Head and Neck Surgery, University of Tennessee Health Science Center, Memphis, Tennessee;

6. American Sleep Apnea Association, Washington, DC;

7. Carolinas HealthCare System Sleep Medicine, Charlotte, North Carolina;

8. Department of Medicine, University of Kentucky College of Medicine, Lexington, Kentucky;

9. Department of Medicine, Perelman School of Medicine, Philadelphia, Pennsylvania;

10. Psychiatry and Behavioral Sciences, Stanford Center for Sleep Sciences and Medicine, Redwood City, California;

11. Department of Otolaryngology Head and Neck Surgery, Henry Ford Health System, Detroit, Michigan

Publisher

American Academy of Sleep Medicine (AASM)

Subject

Clinical Neurology,Neurology,Pulmonary and Respiratory Medicine

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