Insomnia — Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia
Citation(s)
Almeida OP, Alfonso H, Yeap BB, Hankey G, Flicker L Complaints of difficulty to fall asleep increase the risk of depression in later life: the health in men study. J Affect Disord. 2011 Nov;134(1-3):208-16. doi: 10.1016/j.jad.2011.05.045. Epub 2011 Jun 15.
Buysse DJ Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193. Review.
Eaker ED, Pinsky J, Castelli WP Myocardial infarction and coronary death among women: psychosocial predictors from a 20-year follow-up of women in the Framingham Study. Am J Epidemiol. 1992 Apr 15;135(8):854-64.
Haynes PL, Parthasarathy S, Kersh B, Bootzin RR Examination of insomnia and insomnia treatment in psychiatric inpatients. Int J Ment Health Nurs. 2011 Apr;20(2):130-6. doi: 10.1111/j.1447-0349.2010.00711.x.
Kyle SD, Morgan K, Espie CA Insomnia and health-related quality of life. Sleep Med Rev. 2010 Feb;14(1):69-82. doi: 10.1016/j.smrv.2009.07.004. Epub 2009 Dec 4. Review.
Mallon L, Broman JE, Hetta J Sleep complaints predict coronary artery disease mortality in males: a 12-year follow-up study of a middle-aged Swedish population. J Intern Med. 2002 Mar;251(3):207-16.
Morin CM, Belleville G, Bélanger L, Ivers H The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8.
Nilsson PM, Nilsson JA, Hedblad B, Berglund G Sleep disturbance in association with elevated pulse rate for prediction of mortality--consequences of mental strain? J Intern Med. 2001 Dec;250(6):521-9.
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.
