Flygare J, Parthasarathy S Narcolepsy: let the patient's voice awaken us! Am J Med. 2015 Jan;128(1):10-3. doi: 10.1016/j.amjmed.2014.05.037. Epub 2014 Jun 12.
Javaheri S, Caref EB, Chen E, Tong KB, Abraham WT Sleep apnea testing and outcomes in a large cohort of Medicare beneficiaries with newly diagnosed heart failure. Am J Respir Crit Care Med. 2011 Feb 15;183(4):539-46. doi: 10.1164/rccm.201003-0406OC. Epub 2010 Jul 23.
Leung RS, Bradley TD Sleep apnea and cardiovascular disease. Am J Respir Crit Care Med. 2001 Dec 15;164(12):2147-65. Review.
Marin JM, Carrizo SJ, Vicente E, Agusti AG Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53.
Peker Y, Carlson J, Hedner J Increased incidence of coronary artery disease in sleep apnoea: a long-term follow-up. Eur Respir J. 2006 Sep;28(3):596-602. Epub 2006 Apr 26.
Peppard PE, Young T, Palta M, Skatrud J Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84.
Tregear S, Reston J, Schoelles K, Phillips B Continuous positive airway pressure reduces risk of motor vehicle crash among drivers with obstructive sleep apnea: systematic review and meta-analysis. Sleep. 2010 Oct;33(10):1373-80. Review.
Weaver TE, Grunstein RR Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG. Review.
Weaver TE Outcome measurement in sleep medicine practice and research. Part 1: assessment of symptoms, subjective and objective daytime sleepiness, health-related quality of life and functional status. Sleep Med Rev. 2001 Apr;5(2):103-128.
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.
