Vestibular Disorder — Testing an Intraoral Electronic Balance Aid for Vestibular Imbalance
Citation(s)
Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66. Erratum in: Arch Intern Med. 2009 Aug 10;169(15):1419.
Dozza M, Horak FB, Chiari L Auditory biofeedback substitutes for loss of sensory information in maintaining stance. Exp Brain Res. 2007 Mar;178(1):37-48. Epub 2006 Oct 5.
Tang H, Beebe DJ An oral tactile interface for blind navigation. IEEE Trans Neural Syst Rehabil Eng. 2006 Mar;14(1):116-23.
Tang H; Beebe DJ Design and microfabrication of a flexible oral electrotactile display. Journal of Microelectromechanical Systems. 2003 Feb;12(1):29-36.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
